89 Pharmacokinetics Jobs - Page 2

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products that cater to the needs of underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products cover various therapeutic areas such as cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, benefiting millions of patients worldwide. For more information about Azurity, please visit www.azurity.com. Azurity Pharmaceuticals is committed to fostering an inclusive workplace and is proud to be an Equal Opportunity Employer. The company attributes its success to its talented and dedicated team that prioritizes improving patients" lives by incorporating the best science and commitment to quality in all aspects of its work. Azurity seeks individuals who are highly motivated, possess integrity, dedication, and a creative spirit to excel within the organization. As a part of the Clinical Development team at Azurity, the Manager, Clinical Development plays a vital role in supporting early development activities across multiple therapeutic areas. Reporting to the Director, Clinical Development, the candidate will collaborate with stakeholders and team members to ensure scientific excellence, build effective relationships across Research & Development, and optimize the design and analysis of clinical investigations. **Principle Responsibilities:** - Design studies with a focus on technical, regulatory, and formulation aspects. - Collaborate with program managers and study teams to develop study plans aligned with the overall development plan and key milestones. - Ensure compliance with GCP, local and target regulatory guidelines, study protocols, and identify and address areas of concern. - Oversee study operations, including initiation, monitoring, and closeout, sample shipment, and communication with CROs, involving travel to CRO locations and study sites. - Independently perform non-compartmental PK analysis, PK modeling, and IVIVC communication of trial status and data to cross-functional teams. - Manage data repository, TMF, and critical study documents, proposing alternative strategies to optimize time, cost, and resources. - Contribute to the development, review, and approval of clinical study documents, such as ICF, IB, CRFs, study reports, and regulatory documents. **Qualifications And Education Requirements:** - Master's, Pharm.D, or PhD degree in clinical research, pharmacology, or equivalent field. - Minimum 6 years of pharmaceutical industry experience, with 4-5 years of experience in Phase 1 or 2 clinical development. - Sound understanding of US and ex-US regulatory clinical requirements, drug development continuum, and knowledge of regulatory approval processes. - Familiarity with ICH guidelines, GCP, biostatistics, and pharmacokinetics. - Strong organizational, interpersonal, and communication skills with the ability to work collaboratively in a cross-functional team. - Excellent analytical, problem-solving, and communication skills. By applying for this role, you confirm your ability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have concerns or disabilities that may affect your performance, please inform HR in advance.,

Core Responsibilities: 1. Design and Analyze PK Studies o Plan clinical PK studies synopsis and feasibility o Analyze PK data using modeling and simulation tools (e.g., Phoenix WinNonlin, R software). o Interpret PK parameters such as C_max, AUC, T_max, half-life, clearance, and volume of distribution. 2. Support Drug Development o Provide PK and statistical input in clinical development phase studies protocol o Evaluate food effect, drug-drug interactions (DDIs), and bioavailability/bioequivalence studies and provide scientific inputs for study design & protocol preparation o Support dose selection and optimization strategies for pivotal study design. 3. Regulatory Submissions o Deep understanding and knowledge of regulatory guidance (like US FDA, MHRA, EMA, HEALTH CANADA, ANVISA etc) documents pertain to BABE as well as clinical trials o Prepare and review PK-Statistical sections for regulatory documents (e.g., ANDA, IND, NDA, BLA, CTA). o Respond to Health Authority questions related to pharmacokinetics. 4. Cross-functional Collaboration o Work closely with clinical, bioanalytical, statistical and regulatory teams. o Participate in multidisciplinary project teams to inform decision-making. 5. Data Interpretation & Reporting o Summarize findings in study reports and scientific publications (as applicable). o Present PK data to internal teams and external teams (Sponsor, DSMB and other regulatory bodies) o Experience into study design, protocol writing, through knowledge of regulatory guidance for BA/BE studies as well as PK clinical trials.

Company Description Aizant® is an integrated drug development solutions provider, established by experienced pharmaceutical professionals with global exposure. As a rapidly growing contract research organization (CRO), Aizant partners with health care companies globally to support new molecular entities (NMEs), generics (ANDAs), and over-the-counter (OTC) products. We offer comprehensive solutions across drug development stages including preformulation, formulation development, analytical development, cGMP scale-up, stability, bioavailability, bioequivalence, bioanalysis, pharmacokinetics, and clinical diagnostics. Our mission is to add exponential value to our clients’ R&D programs from molecule discovery to commercialization and life cycle management. Role Description This is a full-time on-site role for a Quality Control Laboratory Manager located in Hyderabad. The Quality Control Laboratory Manager will be responsible for overseeing the daily operations of the quality control laboratory, ensuring compliance with cGMP standards, managing laboratory staff, and maintaining laboratory equipment. Additional responsibilities include developing and implementing quality control procedures, analyzing and interpreting data, and coordinating with other departments to ensure quality assurance throughout the production process. Qualifications Quality Control skills Laboratory Skills and familiarity with Laboratory Equipment Strong Analytical Skills Excellent leadership and team management abilities Strong organizational and communication skills 16 yrs of experience in the pharmaceutical industry

Preferred candidate profile M. Pharm (Pharmacology) / M.Sc. (Biochemistry / Pharmaceutical Chemistry) with 6-9 years or Ph.D. with 2-5 years' experience in PBPK & PK/PD modelling & Gastro plus; Simcyp software Role & responsibilities Experience in the development and application of pharmacometric models to support drug development and regulatory submissions Extensive experience with non-linear mixed effects modelling Proficient with software tools like PBPK models, Phoenix, R, PoPK, QSP modelling or similar platforms Strong background in pharmacokinetics/pharmacodynamics (PK/PD) modelling, First-in-human dose predictions. Collaborate with clinical pharmacology, biostatistics, and other interdisciplinary teams to inform clinical trial designs and data analysis Develop and implement model-based strategies to optimize dosing regimens and therapeutic outcomes Ensure the accuracy and quality of pharmacometric analyses and reports Engage with regulatory agencies and prepare regulatory submission documents related to pharmacometric analyses Stay abreast of the latest developments in pharmacometrics and incorporate new methodologies and technologies as appropriate Present findings and strategies to the project team meeting and cross-functional teams. Ability to work effectively in a team environment.

Preferred candidate profile M. Pharm (Pharmacology / Pharmaceutical Analysis) / M.Sc. (Biochemistry / Pharmaceutical Chemistry / Analytical Chemistry) with 3 - 6 years experience in Bioanalytical DMPK & Invivo PK. Role & responsibilities Planning and execution of invivo preclinical pharmacokinetic studies, invivo tissue distribution & mass balance studies in rodents. Expert in method development of NCEs using LC-MS/MS system Well verse with extraction techniques of molecules from various matrices like plasma/urine/tissues Experienced in surgical skills for rodents PK, excretion studies Conduct Bioanalysis of samples from in-vivo pharmacokinetic, tissue distribution studies, PK-PD & TK studies through LCMS/MS Prepare protocols and SOPs in line with industrys best practices Very strong in basics of all instruments, principles of chromatography, sample processing Knowledge of Phoenix WinNolin software will be added advantage

Role & responsibilities Collaborates with field experts in Research and Pre-Clinical Development to plan, execute and analyze relevant experiments independently, notably design of experiments feasible under given lab conditions, support of sample-size calculations and application for animal testing licenses, randomization, data transfer into appropriate stats software, interpretation of results. Takes statistical responsibility for one or more standard experiments. Develops the statistical analysis plan for the experiments as appropriate, ensuring overall consistency within and between projects. Facilitates the overall organization and coordination of statistical activities for specific experiments and small projects. Leads virtual cross-functional sub-teams within NCS/SIS of DS&AI. Assumes responsibility for the production and accuracy of the statistical deliverables and interpretation of the results. Works independently at routine and complex statistical questions and tasks. Develops and implements standard processes for the analysis of routine experiments. Oversees and ensures accurate and timely delivery of statistical work outsourced to external providers. What we're looking for Qualifications & Competencies: PhD or MSc in Biostatistics, Statistics or Mathematics, or related field. Strong communication skills. Ability to work independently as well as collaboratively, as required. Ability to translate statistical results into biological meaning Good knowledge of statistical programming languages (including SAS and R). Fluent English skills. At least two years as a non-clinical statistician focused on in vivo and in vitro experiments with significant time spent in pharma, biotech or similar sector.

" Jubilant Biosys is looking for Research Associate for DMPK department - Bengaluru location Experience : 3-5 Years Qualification : M. Pharmacy Roles & Responsibilities: Responsible for drug metabolism and pharmacokinetic support for discovery programs. Support preclinical bioanalysis Monitor Pharmacokinetics studies and support bioanalysis Providing pre-clinical ADME lead optimization support to small molecule Drug Discovery programs (Hit Identification to Clinical Candidate Selection) including Inflammation, Neuroscience, Metabolic Disorders and Anti-infective Research. Working as a DMPK subject matter lead in multidisciplinary/cross functional teams of drug discovery projects. Understand the Chemical Structure - ADME relationships and design apt strategies towards improving Drug like Properties of the New Chemical Entities. Understand the broader ADME requirements of various projects Conduct PK and PK/PD analysis through early pre-clinical development, and collaborate in PK/PD and efficacy study designs Collaborate with safety assessment group (in need basis) on study design Design tailor made ADME protocols for various projects Collate the obtained results and prepare presentations for internal and external meetings Contribute to the design of the critical path for various projects Prediction of human pharmacokinetic properties from in vitro and in vivo data Managing PK and PK/PD analysis through early pre-clinical development, and collaborates in PK/PD and efficacy study design developing robust PK/PD models Prediction of human pharmacokinetic properties from in vitro and in vivo data in preclinical species. Collaborates with safety assessment group on study design. Method validations and analytical trouble shooting; Data generation, compilation, report preparation; Lab note book, record keeping; SOP writing ",

" Ju bilant Biosys is looking for Senior Research Associate I - DMPK, Bengaluru Location Experience : 5-7 Years Qualification : M.Pharmacy Roles & Responsibilities: Responsible for drug metabolism and pharmacokinetic support for discovery programs. Support preclinical bioanalysis Monitor Pharmacokinetics studies and support bioanalysis Providing pre-clinical ADME lead optimization support to small molecule Drug Discovery programs (Hit Identification to Clinical Candidate Selection) including Inflammation, Neuroscience, Metabolic Disorders and Anti-infective Research. Working as a DMPK subject matter lead in multidisciplinary/cross functional teams of drug discovery projects. Understand the Chemical Structure - ADME relationships and design apt strategies towards improving Drug like Properties of the New Chemical Entities. Understand the broader ADME requirements of various projects Conduct PK and PK/PD analysis through early pre-clinical development, and collaborate in PK/PD and efficacy study designs Collaborate with safety assessment group (in need basis) on study design Design tailor made ADME protocols for various projects Collate the obtained results and prepare presentations for internal and external meetings Contribute to the design of the critical path for various projects Prediction of human pharmacokinetic properties from in vitro and in vivo data Managing PK and PK/PD analysis through early pre-clinical development, and collaborates in PK/PD and efficacy study design developing robust PK/PD models Prediction of human pharmacokinetic properties from in vitro and in vivo data in preclinical species. Collaborates with safety assessment group on study design. Method validations and analytical trouble shooting; Data generation, compilation, report preparation; Lab note book, record keeping; SOP writing ",

Preferred Candidate Profile: M. Pharm (Pharmacology / Pharmaceutical Analysis) / M.Sc. (Biochemistry / Pharmaceutical Chemistry / Analytical Chemistry) with 5-8 years or Ph.D. with 2-5 years experience. Role & responsibilities Experience in designing, performing, and interpreting metabolite identification studies- Invitro and Invivo. Proficient in using LC-MS/MS, HRMS, and other analytical techniques for identification of metabolites and its soft spots. Ability to analyze complex data sets and structural interpretation for Phase-1, 2, and 3 metabolites. Strong understanding of drug metabolism principles and pathway. Experience with regulatory documentation and submissions Experience in DMPK concepts and provide insights to project teams. Represent the group in internal and external meeting. Ability to work effectively in a team environment. Strong understanding of various concepts of DMPK in large molecule/ADC with excellent communication skills, driving innovation, managing teams is added advantage Responsible for preparation of relevant SOP, protocols, reports, etc. to support various regulatory and non-regulatory submission.

Designation: Research Scientist - Document Reviewer Job Location: Bangalore Department: Clinical Development About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R& productivity, speed up time to market and lower the cost of innovation. Job Purpose: The position holder is responsible for document review related to Bioanalysis, including Pharmacokinetics and Immunogenicity. Key Responsibilities: Review technical documentation and record review in a report Provide assistance/participate for the preparation of SOPs etc. Execution of review documents in accordance with planned timelines Technical data reviews for studies utilizing analytical skills, technical knowledge and utilizing excellent regulatory guidelines requirements Capable to focus attention to detail review and identify critical observations Routine review of laboratory log books, equipment calibration and validation status etc. Handle multiple studies data review simultaneously in an efficient and effective manner. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted company Educational Qualification: Master s degree in Biological Sciences (Preferably Biochemistry background) or a related field. Technical/functional Skills: Good knowledge of MS Office applications is necessary Handling audits and participation in audits is preferable Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines. Experience: 12-15 years of total experience in Document review. Behavioral Skills: Should be independent. Excellent communication skills - written and oral in English Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressure Equal Opportunity Employer: .

Company Description Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait . We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). ‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization. Job Description Job Summary We are looking for an adept leader to spearhead Medical Affairs in Emerging Markets across therapy areas. The role is integral to achieving disease and therapy area leadership, improving product access, conducting impactful scientific initiatives, contributing to evaluating new products, fostering KOL (Key Opinion Leaders) connections, planning evidence generation, and guiding marketing teams for compliance. Roles & Responsibilities You will be responsible for reviewing and approving promotional inputs, ensuring compliance with SOPs (Standard Operating Procedures) and regulations, with a target of 90% approval within 2 to 5 working days. Your role involves organizing webinars, CMEs (Continuing Medical Education), ISPs (Investigator-Sponsored Program), advisory board meetings, and preceptorship programs for various countries, including preparation of scientific agendas, providing literature and presentations, and coordinating with faculties for ISPs. You will provide strategic support for new and existing products, developing medical strategy for new launches, offering strategic inputs for existing products, and contributing to communication development. You will be responsible for ensuring compliance in medico-marketing activities, including print/digital input approvals, other medical affairs activities, selection of speakers, deciding FMV, and evaluating participation criteria. You will lead evidence generation activities and publications for major products across Emerging Markets (EM) countries. You will be responsible for the evaluation of new products, identifying products to build a robust portfolio across therapy areas. Your role involves providing medical rationale and analysis for selected products to BD (Business Development), Portfolio, and CoE (Center of Excellence) teams. You will conduct Advisory board meetings to gather the opinions of Key Opinion Leaders (KOLs) on new products. Additionally, you will prepare target product profiles for proposed differentiated products, including details on the rationale, desired pharmacokinetics, and endpoints to be studied in various stages of drug development. You will also create slides on the medical rationale of differentiated products and present them to internal approval committees and regulatory bodies for necessary approvals. You will be responsible for conducting training sessions and preparing slides or manuals for new launches with CoE and country teams in EM, and conducting sessions on scientific updates on existing products. You will compile recent conference updates and circulate them to CoE and the Marketing team in EM for each therapy area. Your role involves providing regular periodic updates on major brands/therapy areas and supporting digital activities such as websites for doctors, Medznat in APAC (Asia-Pacific) countries, video review and approval for digital platforms, digital content quality review and revision, and support for website launch and webinars/CMEs for digital platforms. Qualifications Educational qualification: An M.D. Minimum work experience : 7 to 8 years of relevant experience from reputed pharmaceutical companies in GLP-1 therapy area Skills & attributes: Technical Skills Experience in clinical research, and in -depth knowledge of regulatory standards in the pharmaceutical and medical field Technical Skills in organizing and managing diverse events. Knowledge and experience in developing strategic medical plans for new product launches and providing valuable inputs for existing products. Expertise in leading evidence generation activities and publications for major products in EM (Emerging Markets). Ability to evaluate new products, identify portfolio enhancement opportunities, and conduct advisory board meetings for gathering key opinion leader insights. Proficiency in managing digital activities, including websites, video reviews, digital content quality review, and approval for various platforms. Skills in conducting training sessions. Proficiency in regular usage of computers. Behavioural Skills Keen attention to detail for ensuring accuracy in promotional inputs, compliance reviews, and event coordination. Effective communication for collaborating with cross-functional teams, coordinating events, and providing strategic support Ability to convey complex medical concepts to diverse stakeholders. Ability to adapt to changing regulatory requirements, market conditions, and evolving product portfolios. Strong organizational and time management skills for handling multiple tasks and priorities. Ability to influence and guide teams, especially in cross-functional collaborations. Additional Information About the Department Emerging Markets Branded generics is one of our biggest businesses in Emerging market and our branded products are available 48 countries across 5 regions. Our key markets are Russia, China and Brazil. We also have presence in Latin America, Africa, Australia, New Zealand, ASEAN (Association of Southeast Asian Nations), CIS and Romania. We have added 13 new geographies in the last 5 years. In the last 4 years, our emerging markets business’ growth rate has doubled (June ’22). Our diverse portfolio spans all segments. We are continuously advancing technologies, enhancing efficiency of operations and increasing our portfolio of highest-quality quality products. With nearly 40 products and 6 mega brands, Russia is a key market. With more than 30 years of operations in the region, as of FY22, we have reported a year-on-year growth of 32%. This was driven by improved existing business performance, launch of new products during the year along with divestment of some non-core brands. 6 key products were ranked among the top 200 bestselling formulation brands, as per IQVIA in its report for the 12-month period ended 31 March, 2022. 5 of our leading products were voted as the ’Product of the Year’ by the consumers – reaffirming the trust that the people of Russia have in them. We are among the earliest Indian pharma companies to have a business presence in China. We have a representative office that focuses on filings and approvals, including the Group Purchasing Organisation (GPO). Our joint venture entity (Kunshan Rotam Reddy Pharmaceutical Co. Ltd) offers a portfolio of niche and essential products, strengthening our presence in China. In Latin America we have a strong presence in Brazil and Colombia. In just a little over five years in Brazil, our team has established itself in the region with our diverse portfolio. Our primary focus in Brazil is oncology and institutional. Our team in Colombia was certified as a ‘Great Place to Work’. Through our comprehensive COVID-19 portfolio, we were able to reach over 5 million patients in low and middle-income countries. With the aim of reaching more and more patients around the world, we are harnessing our deep science capabilities to create a robust portfolio in the region to become the partner of choice. Our teams in China, Brazil, Colombia and Thailand, Malaysia are a certified great place to work. Our team in Russia is among the top 3 in Head-hunter’s Best Employer Ranking in 2022. These recognitions reaffirm our commitment and efforts to bring science, technology and innovation together to offer affordable medicines and solutions beyond the pill to patients in the region. As the need, scope and standards of healthcare evolve, we keep track of emerging needs to contribute to patient welfare. After all, Good Health Can’t Wait Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

About the job: We are seeking a skilled Data Platform Engineer with expertise in High-Performance Computing (HPC) and cloud computing to support our scientific research activities globally (Canada, US, France and Germany mostly). The ideal candidate will have experience in managing and optimizing Linux-based HPC environments, as well as proficiency in AWS cloud services. This role involves collaborating with various R&D groups to provide technical support and drive continuous improvements in our computing infrastructure. The candidate should be adept at handling both open-source and commercial software across different R&D fields. What you will be doing: Support in-silico activities in the Boston area, including the installation, configuration, and optimization of Linux workstations and applications. Provide continuous improvements and maintenance of the current Linux environments. Manage and optimize AWS cloud resources, including key services such as Amazon FSx for Lustre, EC2, S3… Collaborate with research teams to understand their computational needs and provide tailored solutions. Ensure the security, scalability, and efficiency of cloud-based scientific workflows. Troubleshoot and resolve technical issues in both on-premises and cloud environments. Handle the compilation, installation, and maintenance of open-source software and commercial applications. Stay updated with the latest advancements in HPC and cloud technologies to recommend and implement improvements. Main responsibilities: - Proven experience in managing and optimizing Linux-based HPC environments. Strong proficiency in AWS cloud services, particularly Amazon FSx for Lustre, EC2, S3. Knowledge of cloud architecture, including network design, storage solutions, and security best practices. Familiarity with scripting languages such as Bash, Python, or Perl for automation and system administration tasks. Experience with containerization technologies like Docker and orchestration tools like Kubernetes. Ability to compile, install, and maintain open-source software and commercial applications. Strong problem-solving skills and the ability to work independently and in a team. Excellent communication skills to collaborate effectively with researchers and technical teams. Bachelor's or Master's degree in Computer Science, Engineering, or a related field. Preferred Qualifications: Experience with other cloud platforms (e.g., Google Cloud, Azure). Knowledge of bioinformatics or scientific computing workflows. Experience in working with HPC schedulers (SLURM, PBS, Grid Engine etc…) Familiarity with Infrastructure as Code (IaC) tools like Terraform or CloudFormation. Certifications in AWS or other cloud platforms. Experience with software tools in various R&D fields, such as: Drug Design and Molecular Modeling: Schrödinger, Moe, Amber, Gromacs, NAMD, AlphaFold. Genomics and Data Analysis: NGS pipelines (Cellranger), KNIME, R/RStudio/RShiny. Pharmacokinetics and Clinical Simulations: Monolix, Matlab, R/RStudio, Julia. Structural Biology and Imaging: CryoSparc, Relion, CCP4, Pymol. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. Pursue Progress . Discover Extraordinary . Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue Progress. And let’s discover Extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Job Title : Study Director - Pharmacokinetics and Immunogenicity Assays Job Location: Bangalore Department: Immunogenicity Research Laboratory - Translational & Clinical Research Job Purpose: The position holder is responsible for performing bioanalysis which includes performing ligand binding assays related to Pharmacokinetics and Immunogenicity. Key Responsibilities: Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures. Regular interaction and participation with Study director, Quality Control (QC) and Quality Assurance (QA) during raw data and reports review, closure of observations and archival. Will be involved in strategic planning for project execution, documentation of data, data analysis, interpretation and presentation of the results • Ensure to complete the assigned tasks in timely manner. Actively involved in preparation of SOPs, protocols, method and reports Prepare reagents, buffers and maintain log book for assigned assays Interpret results - anticipate and understand the issues related to the assay. Participate in, and present data for discussions. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted company Educational Qualification: Master's degree or Ph.D in Biological Sciences (Preferably Biochemistry background) or a related field Technical/functional Skills: Should have a strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols. Should have hands-on experience in Ligand Binding Assay (LBA) development, validation and Sample analysis. Knowledge of ELISA and MSD assays are highly desirable. Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines. • Manuscript writing ability is preferable Proficiency in software like Laboratory Information Management System (LIMS), GraphPad, Adobe etc. Experience: 7+ years of experience in immunoassay laboratory. (CRO experience is preferable). Behavioral Skills: Ability to work independently as well as with team members A strong proactive and independent thinker • Excellent communication skills - written and oral in English Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressure Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role About the Role: The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision. Proposes and leads implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level. Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e. g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Minimum requirements MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 5+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics . Commitment to Diversity and Inclusion: Accessibility and accommodation Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Date: 7 Jul 2025 Location: Bangalore, KA, IN, 560100 Custom Field 1: Discovery Services Designation: Research Scientist – Document Reviewer Job Location: Bangalore Department: Clinical Development About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R& productivity, speed up time to market and lower the cost of innovation. Job Purpose: The position holder is responsible for document review related to Bioanalysis, including Pharmacokinetics and Immunogenicity. Key Responsibilities Review technical documentation and record review in a report Provide assistance/participate for the preparation of SOPs etc. Execution of review documents in accordance with planned timelines Technical data reviews for studies utilizing analytical skills, technical knowledge and utilizing excellent regulatory guidelines requirements Capable to focus attention to detail review and identify critical observations Routine review of laboratory log books, equipment calibration and validation status etc. Handle multiple studies data review simultaneously in an efficient and effective manner. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted company Educational Qualification Master’s degree in Biological Sciences (Preferably Biochemistry background) or a related field. Technical/functional Skills Good knowledge of MS Office applications is necessary Handling audits and participation in audits is preferable Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines. Experience 12-15 years of total experience in Document review. Behavioral Skills Should be independent. Excellent communication skills - written and oral in English Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressure Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role About the Role: The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision. Proposes and leads implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level. Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Minimum requirements MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 5+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics . Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Division Development Business Unit Innovative Medicines Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Designation: Lead-Biostatistician Job Location: Bangalore Department: Biometrics About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation . Job Purpose (1-2 Lines): To perform Biostatistical activities in Biometrics Department for Clinical Studies Phase 1-4 Key Responsibilities: (Maximum 5-8 Points) Reviewing protocol SAP & RAP preparation and implementation Sample size calculation Provides statistical consultations Preparing and reviewing randomization list Preparing and reviewing of tables, listing and graphs, as applicable Preparing and reviewing of statistical report, as applicable Provides support for blinding and unblinding documentations Preparing and reviewing standard operating procedures Training/Guiding/Mentoring associate biostatisticians and junior programmers. Objectives setting and appraisal for the team Facing client to answer statistical queries Any other responsibilities assigned by the organization from time to time Educational Qualification: M. Sc. in Statistics, Ph. D. in Statistics or any equivalent degree in Statistics Technical/functional Skills: (Maximum 4-6 Points) Expert in any programming language (preferably R and SAS) Clinical Trials Exposure Pharmacokinetics and Phase I-IV Experience: 10-15 Years Behavioral Skills: Proficient in English (reading and writing), Stress Management, Empathy, Conflict resolution and Patience Equal Opportunity Employer: .

About Us: Arjuna Natural Private Limited is India’s leading manufacturer and exporter of standardized botanical extracts for the pharmaceutical and nutraceutical industries for more than two decades. Established in 1989, the company has grown in epic proportion with customers in around 60 countries and has several international patents to its credit of which the majority are commercialized globally. The company has an R&D tie-up with international universities from Australia, the US, and Japan. The highly advanced R&D unit at Arjuna is a complete research facility for phytochemistry, pharmacokinetics, formulation, development, and pre-clinical studies. Arjuna’s state-of-the-art laboratory has been approved for in-house research by the Ministry of Science & Technology, Government of India. Arjuna Natural Private Limited is now on the path of transformation to new business styles and heights. Becoming professionally driven with an international reputation is the current goal. At this juncture, the Management of Arjuna Natural Private Limited plans to bring standards into business operations overall as a group. Department: Manufacturing / Operations Location: Kochi Reporting To: Production Manager / Plant Head Job Summary: We are looking for a motivated and detail-oriented Production Engineer with a background in Chemical Engineering and 1–4 years of experience in a manufacturing environment. Experience in Solvent Extraction processes will be considered a strong advantage. The ideal candidate will ensure efficient production operations, maintain process parameters, and drive continuous improvement initiatives. Key Responsibilities: Monitor and manage daily plant operations to ensure optimal performance and efficiency. Maintain and control process parameters related to solvent extraction and related chemical processes. Coordinate with maintenance and quality departments to reduce downtime and ensure product quality. Ensure adherence to safety, environmental, and GMP standards. Assist in troubleshooting process issues and implementing corrective actions. Maintain documentation of production data, batch records, and reports. Participate in process optimization and lean manufacturing initiatives. Train and supervise operators and technicians on standard operating procedures. Qualifications & Skills: Education: B.Tech / B.E. in Chemical Engineering Experience: 0-4 years of experience in a production or process engineering role Preferred: Experience in Solvent Extraction or oil-based processing industries Strong analytical and problem-solving skills Working knowledge of plant safety standards and process control systems Excellent communication and team coordination skills

Job Description 1. Collate and present literature review on preformulation, physico-chemical characterization, stability, bioavailability / pharmacokinetics of molecules to aid complex generic product development. Application of fundamental understanding of Pharmaceutical Sciences, Biopharmaceutics, Pharmacokinetics & Biostatistics in generic formulation design. 2. Lead the effort towards reconstruction/ reverse engineering of innovator formulation including preformulation studies, evaluation of API & in-house formulation using modern analytical, imaging and characterization techniques. 3. Responsible for brain storming with team and clarification of ideas aimed at development of discriminatory and bio-relevant dissolution methodologies, review and validation of data generated from this effort with the objective of providing the formulation team tools that aid in systematic deduction of formulation variables and improving the BE hit rates. 4. Supervise & perform preformulation studies for complex generic formulations and develop innovative methods to perform RLD characterization studies to aid development of formulation/manufacturing strategies for complex generic products. 5. Lead the team in developing prospective in vitro/in vivo model for new projects- Connecting RLD design and reported in vivo (PK) results to build targeted dissolution profile & dissolution methodologies before initiation of actual development. 6. Perform retrospective/ prospective biopharmaceutical modeling of in vitro/in vivo data of complex generics with an objective of establishing IVIVR/C. Dissection and meta-analysis of pilot/ pivotal BE data- Using systematic deduction & statistical approaches. 7. Document methods and results from dissolution studies, biopharmaceutical modeling, preformulation studies and RLD characterization experiments. And to prepare reports/presentations for project discussions with the formulation development group Work Experience PhD with 3-5 years experience/ Fresh PhD/ Post Doc in Pharmcokinetics (PK) and Biopharmaceutics to consider as M1 Education Masters Doctorate in Pharmaceutical Technology Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility

Rama Super Speciality Hospital is looking for Professor Pharmacology to join our dynamic team and embark on a rewarding career journey Professor is a full-time academic position in a college or university, responsible for teaching, conducting research, and serving on committees They play a critical role in contributing to the intellectual life of their institution and in preparing the next generation of professionals and leaders Responsibilities:Teach a range of courses in the department, at both the undergraduate and graduate levels Conduct original research in the field and publish findings in academic journals and at conferences Advise students and mentor junior faculty members Participate in department and university-wide committees, such as curriculum committees and search committees Pursue external funding opportunities to support research and teaching activitiesEngage in professional development activities to stay current in the field and enhance teaching skills Requirements:A record of successful teaching and research, with a strong publication record in academic journals Ability to teach a range of courses in the department, at both the undergraduate and graduate levels Strong communication and interpersonal skills, with the ability to mentor students and junior faculty membersA commitment to continued professional development and growth

Job description Job title: Senior Associate Scientist Job location: Bangalore Job grade: 8-II About syngene: syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and sops, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: As a Study Director - Toxicology: Responsible for ensuring that GLP toxicology studies; acute, repeat dose and reproduction are carried out to the required scientific and regulatory standards as per Global regulatory guidelines [ICH/OECD]. Function as single point of study control, overall responsibility for the scientific, technical and regulatory conduct of studies, scientific interpretation, documentation and reporting of results. Role Accountabilities: Study Director for in vivo toxicology studies Coordination with local cross-functional teams like veterinary science, biopharmaceutics, bioanalysis, pharmacokinetics or in vitro biology before, during and after execution of toxicology studies Conduct of in-life phases of toxicology studies in rats, mice and rabbits Dose administration in rats, mice and rabbits with various routes of administration Use of on-line data capture system- Pristima Blood sample collection for toxicokinetic Assistance during necropsy activities such as organ weighing, data entry in PROVANTIS software Assistance in conducting rabbit electrophysiology studies Coordination with veterinary science team IAEC meetings- preparation and maintenance of FORM-B and FORM-D Blood collection in rats and mice via different routes for clinical pathology analyses Preparation and following of in-house SOPs Co-ordination for preventive maintenance and calibration of instruments. Archival of materials from toxicology studies. Any other duties given from time to time by the line manager Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 3-6 years Skills and Capabilities: 1. Good understanding and hands on Experience of toxicology. Preferably have knowledge of related disciplines, toxicokinetics, pathology and analytical chemistry. 2. Candidate working in or have relevant experience in contract research organization will be preferred. Education MVSc Equal Opportunity Employer: .

Job Title : Study Director - Pharmacokinetics and Immunogenicity Assays Job Location: Bangalore Department: Immunogenicity Research Laboratory - Translational & Clinical Research About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R& productivity, speed up time to market and lower the cost of innovation. Job Purpose: The position holder is responsible for performing bioanalysis which includes performing ligand binding assays related to Pharmacokinetics and Immunogenicity. Key Responsibilities: Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures. Regular interaction and participation with Study director, Quality Control (QC) and Quality Assurance (QA) during raw data and reports review, closure of observations and archival. Will be involved in strategic planning for project execution, documentation of data, data analysis, interpretation and presentation of the results Ensure to complete the assigned tasks in timely manner. Actively involved in preparation of SOPs, protocols, method and reports Prepare reagents, buffers and maintain log book for assigned assays Interpret results - anticipate and understand the issues related to the assay. Participate in, and present data for discussions. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted company Educational Qualification: Masters degree or Ph.D in Biological Sciences (Preferably Biochemistry background) or a related field Technical/functional Skills: Should have a strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols. Should have hands-on experience in Ligand Binding Assay (LBA) development, validation and Sample analysis. Knowledge of ELISA and MSD assays are highly desirable. Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines. Manuscript writing ability is preferable Proficiency in software like Laboratory Information Management System (LIMS), GraphPad, Adobe etc. Experience: 9-12 years of experience in immunoassay laboratory. (CRO experience is preferable). Behavioral Skills: Ability to work independently as well as with team members A strong proactive and independent thinker Excellent communication skills - written and oral in English Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressure Equal Opportunity Employer: . #LI-JK1

You Get To Collaborate On Work closely with discovery specialists, disease area scientists and in vivo team members. Handling of laboratory animals like rat, mice, Guniea Pig and Rabbits. Dose administration to experimental animals by different routes and small animals surgery (like cannulations, CSF fluid collection) and handling, followed by compound dose preparation, administration to experimental animals. Contributing to the ongoing drug discovery programs by conducting in vivo DMPK studies for NCEs with a good knowledge of in vivo animal models. Data generation, analysis, compilation, report preparation. Regular uploading of the data. Conduct statistically supported data (analysis using win online) and deliver results in a timely manner to enable informed decision-making Understanding systems, processes, and compliance. Prepare, review, and deliver scientific presentations for internal/external use. Participate in cross-functional team activities, add value to research projects through creative ideas. Learn from top-notch drug discovery scientists across the world and opportunity to get trained in people skills. PK-PD studies in rat and mice of NCE. Who will thrive in this role M.Pharm / M.S in Pharmacology with 3-5 years of research experience in either academic or industrial R&D setting. Deep understanding in pharmacokinetics, physiology along with in vivo disease model development and testing. Prior experience in small animal handling, dosing through different routes of administration, dissections and tissue harvesting, tissue processing Fair understanding about the drug discovery process. Excellent organizational, interpersonal, and problem-solving skills Experience of working with different cross functional teams. Excellent oral and written communication skills Strong work ethic; scientific curiosity; can-do, will-do attitude. Experience in using electronic lab notebook system. If you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience.

You Get To Collaborate On Work closely with discovery specialists, disease area scientists and in vivo team members. Handling of laboratory animals like rat, mice, Guniea Pig and Rabbits. Dose administration to experimental animals by different routes and small animals surgery (like cannulations, CSF fluid collection) and handling, followed by compound dose preparation, administration to experimental animals. Contributing to the ongoing drug discovery programs by conducting in vivo DMPK studies for NCEs with a good knowledge of in vivo animal models. Data generation, analysis, compilation, report preparation. Regular uploading of the data. Conduct statistically supported data (analysis using win online) and deliver results in a timely manner to enable informed decision-making Understanding systems, processes, and compliance. Prepare, review, and deliver scientific presentations for internal/external use. Participate in cross-functional team activities, add value to research projects through creative ideas. Learn from top-notch drug discovery scientists across the world and opportunity to get trained in people skills. PK-PD studies in rat and mice of NCE. Who will thrive in this role M.Pharm / M.S in Pharmacology with 3-5 years of research experience in either academic or industrial R&D setting. Deep understanding in pharmacokinetics, physiology along with in vivo disease model development and testing. Prior experience in small animal handling, dosing through different routes of administration, dissections and tissue harvesting, tissue processing Fair understanding about the drug discovery process. Excellent organizational, interpersonal, and problem-solving skills Experience of working with different cross functional teamsExcellent oral and written communication skillsStrong work ethic; scientific curiosity; can-do, will-do attitude. Experience in using electronic lab notebook system. If you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience.

Job Summary We are seeking a skilled In Vitro Statistician with 2-7 years of experience to support our research and development teams in statistical analysis of in vitro studies. The ideal candidate will be responsible for designing experiments, analyzing data, and providing statistical insights to support decision-making in pharmaceutical, biotechnology, or life sciences research. Key Responsibilities: Design, develop, and analyze in vitro study experiments, ensuring statistical rigor and accuracy. Apply appropriate statistical models and methodologies for data interpretation. Work closely with scientists, biologists, and researchers to provide statistical guidance in study design and result evaluation. Utilize statistical software (e.g., SAS, R, JMP, or Python) to conduct data analysis, visualization, and reporting. Validate and verify data integrity, ensuring compliance with regulatory guidelines (FDA, ICH, GLP). Develop and review statistical analysis plans (SAPs), study protocols, and technical reports. Support regulatory submissions by preparing statistical documentation and reports. Stay updated with the latest statistical methods and best practices in in vitro research. Required Qualifications & Skills: Master’s or Ph.D. in Statistics, Biostatistics, Bioinformatics, or a related field. 2-7 years of experience in statistical analysis of in vitro studies, preferably in the pharmaceutical, biotechnology, or life sciences sector. Strong knowledge of experimental design, regression models, ANOVA, DOE, and multivariate analysis. Proficiency in statistical software (SAS, R, JMP, Python, or equivalent). Experience with data visualization, trend analysis, and predictive modeling. Understanding of regulatory requirements and compliance standards (FDA, ICH, GLP). Excellent communication skills to present findings to cross-functional teams. Strong problem-solving skills and attention to detail. Preferred Qualifications: Experience in bioassays, pharmacokinetics, biomarker analysis, or toxicology studies. Familiarity with machine learning and AI-based statistical modeling. Knowledge of clinical and preclinical statistical applications.