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15.0 - 19.0 years
0 Lacs
karnataka
On-site
As the General Manager in Veterinary Sciences at Syngene International Ltd., you will lead the BBRC's in vivo research operations within an AAALAC-accredited facility, supporting various therapeutic and functional areas. Reporting to the Executive Director of Veterinary Science at BMS, you will play a crucial role in the Operations Leadership Team, ensuring alignment with global stakeholders and BMS veterinary sciences practices. Your deep veterinary expertise and commitment to operational excellence will be key in developing capabilities and capacity to support BMS's drug discovery portfolio. Your responsibilities will include leading the Veterinary Sciences BBRC function to provide high-quality support for in vivo pharmacology, DMPK, toxicology, and translational research. As a senior member of the Operations Leadership Team, you will collaborate with global stakeholders to align strategies across R&D sites. Ensuring compliance with international regulations and BMS standards, you will oversee local aspects of veterinary care, animal welfare, and vivarium operations. Furthermore, you will lead, coach, and develop a multidisciplinary team to meet departmental objectives while fostering a culture of excellence, collaboration, and continuous learning. Your role will involve driving excellence in animal care practices internally and with external CRO partners, promoting ethical responsibility, scientific rigor, and continuous improvement. Additionally, you will champion a strong Culture of Care, promote the 3Rs (Replacement, Reduction, Refinement), and develop and implement SOPs, training programs, and performance metrics. To qualify for this role, you should possess a PhD in Veterinary Science, board certification in Laboratory Animal Medicine, and eligibility for veterinary licensure in India. With 15+ years of experience in laboratory animal medicine and leadership roles in pharmaceutical or research settings, you should have a proven track record of leading multidisciplinary teams in a global R&D environment. Experience in GLP and non-GLP studies, familiarity with global regulatory frameworks, and expertise in managing vivarium and veterinary functions are essential. Your technical and functional skills should include expertise across multiple species used in pharmaceutical research, strategic and operational acumen, strong interpersonal and communication skills, and the ability to manage multiple projects with resilience and emotional intelligence. Preferred attributes for this role include operational leadership of multi-site or global veterinary functions, scientific innovation in disease model development, and a passion for ethical research and high-performing team development. Syngene International Ltd. is an Equal Opportunity Employer committed to providing integrated scientific services in a diverse range of industries. Join us in our mission to solve complex scientific challenges, improve R&D productivity, and accelerate innovation in the pharmaceutical and biotechnology sectors.,
Posted 3 days ago
1.0 - 3.0 years
1 - 3 Lacs
Bengaluru, Karnataka, India
On-site
We are seeking an expert MSL-Oncology Consultant to represent Company's Medical Affairs as a subject matter expert in Oncology. You will provide scientific and technical leadership, developing credible relationships with external experts and healthcare professionals, and serving as a key point of contact for scientific knowledge. This role involves developing and executing scientific interaction plans, facilitating research initiatives, and supporting internal teams with scientific updates, all while ensuring strict compliance. Roles and Responsibilities: Represent Company's Medical Affairs as a subject matter expert in Oncology and the assigned territory, providing scientific and technical leadership to ensure professional and credible relationships with external experts /HCPs of strategic importance to Company. Serve as a point of contact within the Medical Affairs team for external experts within an assigned geographic area to satisfy their needs for scientific knowledge in the assigned therapeutic area and, when requested, relevant medicines, to support their safe, effective, and appropriate use. Develop and execute scientific interaction plans and cycle plans; contribute to cross-functional account planning, as appropriate. Responsible for appropriate tiering and segmentation of external experts based on guidance from the IFT playbooks and appropriate documentation of HCP interactions and relevant insights in the Veeva CRM and related platforms and systems. Ensure a strong medical and scientific presence for Company in key academic centers by facilitation of research and educational initiatives , while supporting requests for medical and scientific information on products or areas of therapeutic interest to Company. Support internal teams such as sales and marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations. Work collaboratively and cross-functionally with other in-field members while retaining functional independence. Assist in the initiation, oversight, and follow-up of assigned GMA studies and medical projects initiated within the therapeutic area for which the MSL carries responsibility (e.g., registry/database projects, epidemiological studies, post-authorization studies (PMOS), where applicable). Support prioritized interventional studies run by Clinical Development Operations, with study initiation visits, and act as subject matter expert, where applicable, as part of One R&D community. All such activities must comply with applicable local laws, guidelines, codes of practice, SOPs, and R&D SOPs. Ensure that all activities and interactions are conducted with due regard to all applicable local, global, and national laws, regulations, guidelines, codes of conduct, Company policies, and accepted standards of best practice. Skills Required: Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company. Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research will be an added advantage. Ability to comprehensively learn about new subject areas and environments. Excellent written and spoken communication and presentation skills , with a demonstrated ability to develop and maintain strong collaborative relationships with thought leaders, physicians, and other healthcare decision-makers. A good understanding of written and oral English is a must. High customer orientation. Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity. QUALIFICATIONS: MBBS and MD (Preferable). Candidates with an undergraduate degree with relevant years of experience will be considered.
Posted 6 days ago
3.0 - 7.0 years
0 Lacs
navi mumbai, maharashtra
On-site
As a highly skilled chemist with a PhD in chemistry, medicinal chemistry, or a related field, you will utilize your advanced knowledge in organic chemical synthesis to contribute to the identification and development of innovative chemical crop protection active ingredients. While a postdoc experience and prior exposure to crop protection or pharmaceutical research would be advantageous, they are not mandatory. Your proficiency in English language, coupled with qualities like creativity, curiosity, and enthusiasm for driving innovations, will be instrumental in your success in this role. Joining our Fungicide Chemistry team, you will collaborate with a diverse and international group of experts to create cutting-edge solutions that cater to the global market requirements. Your primary responsibility will involve leading an organic synthesis laboratory team, where you will be involved in designing active ingredients, coordinating their synthesis, analyzing their biological activity, and leveraging structure-activity relationships to initiate new designs. Furthermore, you will spearhead multiparameter optimizations, applying medicinal chemistry concepts to bridge the gap between fungi and plants. Your role will require you to operate at the intersection of chemistry, modeling, biology, agronomy, regulatory affairs, and intellectual property. Staying updated with the latest technologies and advancements in organic synthesis, drug discovery, and competitor activities will be crucial. Additionally, you will have the opportunity to establish connections with academia, scientific partners, and technology providers to further enhance your research capabilities. In summary, this position offers a challenging yet rewarding opportunity for a driven individual with a passion for organic chemistry and a desire to make a significant impact in the field of crop protection.,
Posted 6 days ago
5.0 - 9.0 years
0 Lacs
hyderabad, telangana
On-site
You will be responsible for contributing to the reliability, scientific quality, and optimization of project support throughout the entire process from target identification to process development. This will involve performing statistical analyses of data generated in the laboratories using R and potentially other programming languages to generate statistical reports. Additionally, you will play a key role in the development and maintenance of statistical end-user tools. Your expertise will be utilized in representing statistics within various scientific or technology working groups and cross-functional initiatives. To excel in this role, you should possess a strong background in non-clinical statistics as applied to biopharmaceutical development. Your proven experience in industrial statistics, including descriptive and inferential statistics, statistical process control, design of experiments, multivariate data analysis (such as PCA, PLS, and related methods), and statistical modeling and simulation will be crucial. A sound understanding of statistical concepts and techniques, such as predictive modeling and repeated measure ANOVA, is essential. Additionally, familiarity with pharmaceutical research and development, particularly in in-vitro testing, is desirable. Knowledge of CMC regulatory guidelines from organizations such as EMA, FDA, and ICH Quality, as well as QbD principles, will be valuable in this role. Your ability to prepare statistical analyses for regulatory dossiers and ensure compliance with relevant guidelines will be pivotal to the success of the projects you are involved in.,
Posted 2 weeks ago
4.0 - 9.0 years
5 - 10 Lacs
Hyderabad
Work from Office
Job Title: Analytical Scientist Phy-Chem Studies (Agrochemical & Pharma) Company Name: Vivo Biotech Ltd Location: Hyderabad Experience: 5 + Years Industry: Agrochemical / Pharmaceutical Research Job Description: We are seeking a detail-oriented and skilled Analytical Scientist with hands-on experience in conducting Phy-Chem and validation studies for agrochemicals and pharmaceutical compounds. The ideal candidate will have strong knowledge of global regulatory guidelines and be capable of preparing study-related documentation while maintaining audit readiness at all times. Key Responsibilities: Conduct Physico-Chemical studies for agrochemical compounds in accordance with regulatory requirements. Perform method validation studies for agrochemical products as per SANTEE/SANCO guidelines. Execute validation studies for pharmaceutical compounds as per ICH guidelines. Carry out dose formulation analysis to support toxicological and regulatory studies. Prepare and maintain Standard Operating Procedures (SOPs) for newly initiated studies. Develop study plans and compile final study reports as per relevant regulatory guidelines. Ensure all studies are conducted in compliance with GLP, OECD, OPPTS, CIPAC, SANCO, and SANTEE guidelines. Maintain effective communication with Quality Assurance (QA) personnel throughout the study lifecycle. Utilize Microsoft Excel for accurate calculations, data analysis, and result interpretation. Remain audit-ready at all times for sponsor audits, NGCMA inspections, or other regulatory reviews. Desired Candidate Profile: Strong understanding of regulatory frameworks applicable to agrochemical and pharmaceutical studies. Prior experience working in a GLP-compliant environment. Excellent documentation and report writing skills. Detail-oriented with good communication and coordination skills. Flexible and proactive approach, especially regarding audit preparedness. Thanks & Regards G NagaSravani nagasravani.g@virinchi.com
Posted 1 month ago
3.0 - 7.0 years
6 - 9 Lacs
Bengaluru
Hybrid
We are seeking an experienced Recruiter to provide support to Quanticates growing teams, by sourcing and securing candidates for open positions across the business. Job Location: Bangalore (We are seeking candidates who are preferably based in Bangalore, as the position may necessitate occasional visits to the office) Responsibilities: Provide support to all open positions that are assigned to you, and ensure that they are filled within set guidelines, and with quality candidates. Work closely with Hiring Managers to ensure the needs of the Hiring Managers and their roles are fully understood, including an in depth understanding of preferred candidate profiles, skill sets and experience. Ensure individual roles are resourced effectively, using the appropriate mix of advertising, direct approaches, talent mapping, database searching, social media, network connections etc. Ensure candidates are fully briefed before interview about the role, the interview process and the steps required to go through before a decision will be made. Work closely with HR to ensure a seamless on-boarding process for candidates. Role-Specific Duties: Screen all applicants prior to submission to Hiring Managers, ensuring they meet the requirements of the role, carrying out background checks where required and ensuring they legally have the ability to work in the locations they are being submitted for. Arranging interviews and required tests and ensuring Hiring Managers are in a position to be able to make timely decisions about hiring the right candidates for their open roles. Become a subject matter expert for all areas of internal recruitment and employer branding. Ensure accurate and timely tracking within the ATS (Applicant Tracking System). Use all available tools to provide a pipeline of candidates for current and potential positions within Quanticate, ensuring on-going relationships are developed with prospective candidates in the market. Understand the latest trends in the market and positions for which you are recruiting for, and the latest methods of finding skilled experienced candidates. Key Relationships: Head of Internal Recruitment Regular and consistent updates on the stages of open positions. Ongoing support in continuous improvement for the recruitment process Hiring Managers Work closely with Hiring Managers to ensure the needs of the Hiring Managers and their roles are fully understood, including an in depth understanding of preferred candidate profiles, skill sets and experience. HR Work closely with HR to ensure a seamless on-boarding process for candidates Marketing Support any marketing activity to aid candidate attraction and attend careers fairs/conferences where necessary. Preferred candidate profile Must have a good understanding of the recruitment process in a high-end recruitment environment, specifically, the pharmaceutical/life sciences market Must have experience of utilising a variety of resourcing techniques, including headhunting Ability to communicate with all levels within the company. Excellent organisational skills and self-motivation. Ability to interview and communicate with candidates. Ability to negotiate with both external candidates and internal hiring managers
Posted 1 month ago
1.0 - 3.0 years
3 - 6 Lacs
Hyderabad
Work from Office
What you will do In this vital role you will the Project Management Coordinator will play a key role for the management of Research & Documents controlled documents through helping to strengthen and advance Amgens R&D Quality Management System. This role contributes to implementing strategies and to ensure excellence in R&D controlled document management. Roles & Responsibilities: As an integral team member working globally with R&D Quality team members and R&D Business Process Owners to ensure compliance with GCP regulations and other requirements: Provide technical writing and editing expertise to support the generation of robust, well-written R&D controlled documents. Coordinate workflows for R&D documents (e.g., SOPs) in controlled document management system. Oversee workflow completion, updates, tracking status, and follow-up activities. Perform Quality Checks and editing against R&D templates. Assist PM/Quality Lead with writing support during project meetings. Follow step-by-step instructions and perform repetitive tasks accurately Communicate and educate clients on R&D document processes, troubleshooting issues, and resolving complaints Supports Amgens procedural framework so that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity. Coordinate workflows for R&D documents (e.g., SOPs) in controlled document management system Ensures that all procedures are written clearly for the execution of Amgens GCP/GPvP/GLP research regulations within a diverse, complex, and cross-functional team of researchers. Supports the change control of business procedures in a timely manner with a focus on detail and the output of concisely written documentation. Supports incoming procedural change requests, including the assessment of changes (impact to the QMS, including traceability of changes across other document sets. Applies industry standard methodologies for optimal (standardized and lean) procedural documentation, and the use of technology to drive an efficient and effective GCP/GPvP/GLP quality management system What we expect of you Basic Qualifications and Experience: Masters degree and 1-3 years in Pharma and Biotechnology R&D Quality OR Bachelors degree and 3-5 years in Pharma and Biotechnology R&D Quality. Diploma degree and 7-9 years in Pharma and Biotechnology R&D Quality. Functional Skills: Must-Have Skills: Exceptional attention to detail and accuracy in all deliverables. Ability to work independently and proactively in a fast-paced environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx) Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse R&D environment. Complex document management in the R&D space with experience in GCP regulations. Effective communication, critical thinking and problem-solving Good-to-Have Skills: Familiarity with project management tools and methodologies. Knowledge of GCP, GLP and/or GPvP. Experience working in a multinational environment with global teams. Experience within Biotech/pharmaceutical Research, including the application of Global Regulations. Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes. Independent and team work capabilities Operational and compliance-critical administrative support Soft Skills: Excellent verbal and written communication skills. High degree of professionalism and interpersonal skills. Strong problem-solving abilities and adaptability to changing priorities. Collaborative attitude and ability to build positive relationships across diverse teams. Resilience, discretion, and the ability to thrive under pressure
Posted 1 month ago
4.0 - 6.0 years
7 - 10 Lacs
Hyderabad
Work from Office
What you will do The Quality Compliance Manager is a global role and part of the Process Quality team for the R&D Quality Organization. In this vital role you will work with a team of process-focused colleagues who work to complete Amgens Process Quality strategy, which is vital to ensuring that Amgens Research and Development Standards (SOPs and associated documentation) are adequate, clear, and up to all applicable current regulations and quality requirements. The R&D Process Quality team supports the Quality Management System (QMS) across all areas of research at Amgen, including discovery through the full clinical development lifecycle. This team ensures that all Amgens business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. The Process Quality team also ensures that Amgens R&D Business Process Network develops and manages fit for purpose standards (SOPs) that are continuously improved upon using quality by design (QbD), and risk management methods that include QMS analytics showing quality signals and trends. In addition, this individual will help support end users in R&D with the digital quality management system (DQMS) with queries, deviations and Corrective and Preventive Actions (CAPAs). The Quality Compliance Manager will contribute to implementing strategies and providing leadership to ensure excellence in R&D Quality Processes. As an integral team member working globally with Business Process Owners to ensure compliance with regulations and other requirements. Roles & Responsibilities: This role will work both independently and in a team environment. Their primary responsibility is to support continuous improvement initiatives for R&D quality, but they will also be responsible for any other operational or strategy activities assigned. Generate and review process area Knowledge Maps (spider maps, lessons learning, and data processing techniques, stored in a graph-based database for better search, analysis, and visualization) to help determine inherent and residual risks, document risk assessments, and collaborate with Business Process Owners and Quality Leads to ensure accurate risk classification and preventive actions. Supports Amgens procedural framework so that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity. Provide real-time, site-level quality oversight using analytical tools to identify trends, weaknesses, and data quality issues. Perform focused quality control checks on-site and remotely at clinical trial locations, especially key target sites. Offer independent and objective quality advice to local study teams Conduct risk assessments to inform audit site selection and pre-inspection/mock inspection visits. Support site/sponsor inspection readiness and management, including prep, conduct, response, and close-out phases. Ensures that all procedures are written clearly for the execution of Amgens research tasks within a diverse, complex, and cross-functional team of researchers. Supports incoming procedural change requests, including the assessment of changes (impact to the QMS, including traceability of changes across other document sets. Supports the work of Business Process Owners and applies risk-based strategies consistently to identify and mitigate risks towards the continuous advancement of Amgens R&D QMS. Applies industry standard methodologies for optimal (standardized and lean) procedural documentation, and the use of technology to drive an efficient and effective knowledge management system. Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network in order to enable Management Reviews (periodic review by management to ensure QMS health is maintained). Collaborates with other quality professionals within R&D to support the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/ Corrective and Preventative Actions (CAPA). What we expect of you Basic Qualifications and Experience: Masters degree and 4-6 years in Pharma and Biotechnology R&D Quality OR Bachelors degree and 6-8 years of years in Pharma and Biotechnology R&D Quality. Diploma's degree and 10-12 years of years in Pharma and Biotechnology R&D Quality. Functional Skills: Must-Have Skills: Exceptional attention to detail and accuracy in all deliverables. Ability to work independently and proactively in a fast-paced environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx) Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse R&D environment. Good-to-Have Skills: Familiarity with project management tools and methodologies. Knowledge of GCP, GLP and/or GPvP. Experience working in a multinational environment with global teams. Experience within Biotech/pharmaceutical Research, including the application of Global Regulations. Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes. Soft Skills: Excellent verbal and written communication skills. High degree of professionalism and interpersonal skills. Strong problem-solving abilities and adaptability to changing priorities. Collaborative attitude and ability to build positive relationships across diverse teams. Resilience, discretion, and the ability to thrive under pressure
Posted 1 month ago
10.0 - 20.0 years
15 - 25 Lacs
Bengaluru
Work from Office
Job Description We are looking for an experienced and dynamic Team Leader to head our Analytical Research team within the Pharmaceutical R&D division, focused on complex injectable products and 505(b)(2) submissions . This role is ideal for a candidate with a strong background in pharmaceutical R&D , robust team management skills , and deep understanding of injectable formulation analytics . Key Responsibilities Lead and manage the analytical research team supporting complex injectable development. Supervise daily lab operations, resource allocation, and project timelines. Drive method development, validation, and troubleshooting for injectable formulations. Provide scientific leadership and ensure data quality and regulatory compliance. Maintain high team morale and cultivate a positive, collaborative work environment. Guide preparation of analytical documents for regulatory filings (505(b)(2), ANDA, etc.). Impart training, develop team capabilities, and mentor junior scientists. Collaborate closely with formulation, quality, and regulatory teams. Ensure compliance with cGMP, GLP, and internal SOPs. Desired Candidate Profile Qualification: M.Pharm / Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or related field. Experience: 8+ years in Pharmaceutical R&D , minimum 3 years in a leadership/supervisory role . Hands-on experience in analytical method development for complex injectables (liposomes, suspensions, emulsions, etc.). Sound knowledge of 505(b)(2) regulatory pathway . Strong command of analytical techniques: HPLC, GC, spectroscopy, particle size analysis, etc. Proven track record in team leadership, project coordination , and technical problem-solving . Excellent communication and interpersonal skills. Key Skills Analytical R&D, Complex Injectables, Injectable Formulations, Team Management, 505(b)(2), Method Development, HPLC, GC, Troubleshooting, Pharmaceutical R&D, Training & Mentoring
Posted 2 months ago
7.0 - 12.0 years
8 - 9 Lacs
Hyderabad
Work from Office
Method development and validation processes. Ability to plan, coordinate, and execute projects from initiation to completion, Commitment to maintaining Good Laboratory Practices (GLP) Maintenance and preventive maintenance of instruments. Required Candidate profile supervising, mentoring, and guiding both junior and senior research associates. Prep HPLC as part of the overall industry experience. Proven hands-on experience with HPLC and LC-MS techniques.
Posted 2 months ago
7.0 - 12.0 years
8 - 9 Lacs
Hyderabad
Work from Office
Method development and validation processes. Ability to plan, coordinate, and execute projects from initiation to completion, Commitment to maintaining Good Laboratory Practices (GLP) Maintenance and preventive maintenance of instruments. Required Candidate profile supervising, mentoring, and guiding both junior and senior research associates. Prep HPLC as part of the overall industry experience. Proven hands-on experience with HPLC and LC-MS techniques.
Posted 2 months ago
7.0 - 12.0 years
8 - 9 Lacs
Hyderabad
Work from Office
Method development and validation processes. Ability to plan, coordinate, and execute projects from initiation to completion, Commitment to maintaining Good Laboratory Practices (GLP) Maintenance and preventive maintenance of instruments. Required Candidate profile supervising, mentoring, and guiding both junior and senior research associates. Prep HPLC as part of the overall industry experience. Proven hands-on experience with HPLC and LC-MS techniques.
Posted 2 months ago
1.0 - 4.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Job Title: Principal Bio-Statistician-Non clinical statistic Location: Hyderabad About The Job As part of the development of Sanofis pharmaceutical products, the R&D Data Sciences department and more specifically the Statistics department for the Chemical Manufacturing Control (CMC) (CMC Statistics), is responsible for contributing to statistical support, modeling, digitalization, decision-making and filing of new product registration files, Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do Build a career and you can be part of transforming our business while helping to change millions of lives ReadyAs CMC statistician within our Data Sciences/ CMC Statistics youll be supporting the CMC activities for process, analytical methods and formulation development, for several CMC sites in the world, We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible Ready to get started Major Responsibilities Under supervision of Statistical Project Leader and/or Group Head, contribute to the reliability, scientific quality and optimization of project support from target identification to process development, by providing appropriate Non-Clinical statistical support: Accountable for all assigned statistical deliverables related to one study or activities in the Non-Clinical development area: Perform statistical analyses of data from the laboratories using R and possibly other languages (SAS, ?) or standard statistical software used in Sanofi (JMP, SIMCA, internal tools), to deliver statistical reports/memo Contribute to the development and support of statistical end-user tools (mainly RShiny) Participate to internal working groups and contribute to develop state-of-the art methodologies and statistical approaches Respect Policies, Standards, external guidelines and processes Presentation of statistical work package results to project team members and stakeholders About You Experience: Strong expertise in the field of non-clinical statistics applied to biopharmaceutical development Basic knowledge of pharmaceutical research and development process Scientific rigor and demonstrated level of independence to run statistical work packages For positions supporting Process Development/CMC consider the following: Proven expertise of industrial statistics (descriptive & inferential statistics, statistical process control), design of experiments, multivariate data analysis (PCA, PLS and related methods), statistical modelling and simulation Knowledge of CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias), QbD principles and ability to prepare statistical analysis for regulatory dossiers, Use of standard commercial software e-g JMP, SIMCA, MODDE Able to work in departmental computing environment, do advanced statistical analyses using R and possibly other languages (SAS, ?) Soft and technical skills: Excellent interpersonal and communication skills Education: Master in statistics or related discipline Languages: Fluent in English 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 its 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 weeksgender-neutral parental leave, Be part of a collaborative team Work for several sites internationally Be involved in crucial statistical activities for the company like in the regulatory dossiers null
Posted 2 months ago
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