39 Bioanalytical Jobs

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Warsaw (Poland) and London (UK), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Department: Bioanalytical Operations Designation: Research Associate Job Location: Ahmedabad (Gujarat) KEY DELIVERABLES To develop and validate Bioanalytical methods. To process / analyze samples of allotted projects. To operate, calibrate and troubleshooting of LC-MS/MS instruments and other analytical instruments. Preparation of draft and method SOP and to work in-compliance to System/Method Specific SOPs and relevant Plan/Protocol. To ensure training of all required SOPs/documents prior to initiating any related activities. To ensure effective implementation of GLP and 21CFR Part 11 by checking of instrument labels, completeness of logbooks of equipment s and instruments and ensuring the instrument calibrations are done before due date. Work as per OECD GLP principles ALLIED RESPONSIBILITIES EXPERIENCE 2 to 3 years EDUCATIONAL QUALIFICATION M.Pharm/B.Pharm or M.Sc. COMPETENCIES Accountability Communication Work Ethic Initiative Leadership Employment History Technical Knowledge Academic Qualifications Motivation/Initiative Interpersonal / Leadership skills Presentation / Communication skills Impression and Enthusiasm Organizational Culture fit Accomplishments & Strengths Flexibility/Planning & Organizing

Job Position: Study Director Location: Pragnapur, Hyderabad Company: Vivo Bio Tech Ltd Job Role: The Bioanalytical Associate role focuses on supporting in-vitro ADME studies and plasma sample analysis in preclinical drug development. The successful candidate will be integral in analyzing and interpreting bioanalytical data to support early-stage drug discovery efforts. Responsibilities Conduct routine ADME assays, such as protein binding and metabolic stability, to generate key data supporting drug development decisions. Prepare and analyze plasma samples for pharmacokinetic studies, including the measurement of drug concentration, metabolite profiling, and related biomarkers. Analyze data sets, provide scientific interpretation, and communicate results to cross-functional teams in a clear and concise manner. Maintain concise and accurate records of all study activities in accordance with industry guidelines and company policies. Troubleshoot assay issues, propose corrective actions, and implement process improvements to enhance the efficiency and reliability of bioanalytical data. Assist in the coordination of outsourced research studies or other tasks assigned by management. Requirements Bachelors degree in Analytical Chemistry, Biochemistry, or a related field. 5+ years of hands-on lab experience in bioanalysis, with a focus on ADME/PK studies and plasma sample analysis. Hands-on lab experience with ADME screening assays, such as protein binding and microsomal stability. Experience with plasma sample bioanalysis in support of non-clinical pharmacokinetic studies. Experience with LC-MS/MS, HPLC, UPLC, and related analytical techniques for the quantification and characterization of drug candidates in biological samples. Strong analytical and troubleshooting skills with the ability to interpret complex datasets. Nice-to-haves Familiarity with drug discovery and development, especially within preclinical research. Experience with quantitative LC-MS/MS bioanalytical techniques and ABSciex mass spectrometers. Knowledge of relevant bioanalytical software (e.g., Analyst, Prism). Thanks & Regards G NagaSravani|HRD nagasravani.g@virinchi.com

Role & responsibilities 1.Responsible for work planning and review of documents related to In process, DS, DP, stability testing, AMV and AMT activities within quality control laboratory. 2. To effectively plan and monitor shift duties of the QC analytical staff members to support 24*7 business operations. 3. Responsible for compliance to internal, external & statutory compliances as per quality policy of Enzene, pharmacopoeia guidelines and other regulated guidelines. 4. Responsible for periodic training management related to quality, GMP, regulatory aspects to quality control laboratory personnels and evaluation of effectiveness. 5. Responsible for the periodic assessments/audits to identify gaps / improvement opportunities for strengthening the quality & regulatory compliance. Prepare remediation/mitigation plan (CAPA) and execute it in a timely manner by coordinating cross functionally to uplift the level of compliance’s. 6. Responsible for review and approval of documentation such as SOP’s, Specifications, STP’s, TDS, reports for IRS analyst qualification, protocols, Qualifications and reports etc. 7. Responsible for investigations and approval of OOS, OOT and deviations. To recommend and approve CAPA, change controls. 8. To release or reject the samples handled in quality control laboratory.

Roles and Responsibilities : Responsible for drug metabolism and pharmacokinetic support for drug discovery programs. Develop and validate Bioanalytical method using LC-MSMS and other sophisticated instruments. Have a thorough knowledge of LC-MSMS, HPLC. Have knowledge of USFDA, MHRA, and M10 guidelines. Have excellent communication skills and the ability to co-ordinate with team members. Process good interpersonal and management skills. Strong basic knowledge of Operation, Calibration, and maintenance of laboratory equipment viz. Analytical balance, pH meter, centrifuge, Solid phase extraction unit and evaporator, and pipettes. Active involvement in method development of drug in In-vitro/In-vivo matrixes. Support and process analysis of biological samples for drug/metabolites concentration for preclinical bioanalysis. Handling and the operations of LC-MS/MS and HPLC. Develop self and always maintain knowledge in the relevant field. Preparation of standard operating procedure(SOP), Method validation report, Method book, and method SOP writing, Data generation, compilation, and Lab logbook record maintain. Subject Sample Analysis and literature search. Maintaining GLP in the Laboratory.

Review Validation protocol, Chromatography Raw Data, Validation, Study Report, BA Report, in process report, responsible for providing response to QA. Required Candidate profile knowledge of Bioanalytical Data Review Prefer Ready to work in first and second shift MSc ,M.Pharma / B.Pharma with Bioanalytical data review experience will prefer. Perks and benefits 5 Days week, Bus Facility, Birthday Leave, 28 PL

Job Summary: The Lab Technician is responsible for performing routine and specialized laboratory tests, preparing samples, maintaining lab equipment, and ensuring the accuracy and reliability of test results. This role supports research, development, quality control, or clinical analysis activities within the laboratory. Key Responsibilities: Collect, prepare, and analyze samples according to standard operating procedures (SOPs). Perform routine laboratory tests and record results accurately. Calibrate, maintain, and clean laboratory equipment and instruments. Maintain laboratory inventory, including reagents, supplies, and equipment. Ensure adherence to safety protocols and maintain a clean and organized workspace. Assist in documenting test procedures and results for reports. Troubleshoot and report any technical issues or discrepancies. Support research and development projects by providing technical assistance. Follow quality control and quality assurance procedures to maintain lab standards. Comply with all relevant regulatory and safety standards.

Bioanalytical Custodian experience in CRO. Custodian for plasma sample storage and reference substance. Required Candidate profile Candidate should be able to do shift duty. Perks and benefits Mediclaim, 28 PL, 5 Days working, Birthday Leave

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Having knowledge of fundamental Quality Assurance programme and Quality management Systems. Perform the System audits of Bioanalytical operations to assure compliance to SOP and applicable Regulations. To perform retrospective audits of raw data, MV report, BA report Knowledge of current regulatory guidelines & technical knowledge of bioanalytical operations EXPERIENCE Fresh or experience of more than 1-2 years QA/QC or worked in bioanalytical lab EDUCATIONAL QUALIFICATION B.Sc./M.Sc./B.Pharm/M.Pharm, Science gradute/post graduate

Responsibilities Collaborate with clients to understand their business requirements and translate them into cloud-based solutions, Design and architect scalable, reliable, and secure cloud solutions on platforms such as Amazon Web Services (AWS), Microsoft Azure, or Google Cloud Platform (GCP), Conduct cloud assessments and provide recommendations on cloud migration strategies, including lift-and-shift, re-platforming, or refactoring, Develop architecture blueprints, diagrams, and documentation that clearly articulate the proposed solutions, Work closely with development teams to ensure cloud architecture best practices are followed throughout the software development lifecycle, Assist in the evaluation and selection of cloud services, tools, and frameworks to meet project requirements, Implement and configure cloud services, infrastructure, and networking components as required, Ensure security and compliance of cloud solutions by implementing appropriate security controls and following industry best practices, Collaborate with operations teams to optimize cloud resource utilization, monitor performance, and troubleshoot issues, Stay up to date with the latest cloud technologies, trends, and best practices, and share knowledge with the team and clients, Candidate requirements: Bachelors degree in computer science, Information Technology, or a related field, Proven experience as a Cloud Solution Architect or a similar role, with a deep understanding of cloud technologies and architectures, Strong knowledge of cloud platforms such as AWS, Azure, or GCP, including their core services and capabilities, Experience designing and implementing scalable, reliable, and secure cloud solutions, Familiarity with cloud migration strategies and patterns, Knowledge of cloud security principles and best practices, Proficiency in infrastructure-as-code (IaC) tools and techniques, such as Terraform or CloudFormation, Strong problem-solving and analytical skills, with the ability to understand complex requirements and propose appropriate cloud solutions, Excellent communication and presentation skills, with the ability to effectively communicate technical concepts to both technical and non-technical stakeholders, Relevant certifications such as AWS Certified Solutions Architect, Microsoft Certified: Azure Solutions Architect, or Google Cloud Certified Professional Cloud Architect, Experience with DevOps practices and CI/CD pipelines is a plus

- Collaborate with project managers to define scope, timelines, and deliverables - Ensure timely and effective execution of clinical trial software solution projects - Provide consulting for CTMS platform implementation, configuration Required Candidate profile - Advise on solution architecture, workflows, and usability enhancements in CTM systems - Validate the alignment of software features with clinical workflows and regulatory requirements Perks and benefits -GPA &term Insurance -5 days week -open to discuss

Job Summary: We are looking for a highly skilled and experienced Clinical Research Scientist with a strong background in Bioequivalence and Bioavailability (BE/BA) studies and clinical operations . The ideal candidate will have over 10 years of experience in the pharmaceutical industry, with a minimum of 7 years in BE/BA studies, and a deep understanding of regulatory requirements for highly regulated markets including USFDA, EMA (EU), and Health Canada . This role also involves overseeing clinical trials as a Sponsors Representative , managing end-to-end clinical processes, ensuring regulatory compliance, and coordinating with various stakeholders for successful study execution and documentation. Key Responsibilities: BE/BA & Regulatory Focus: Design and oversee Bioequivalence and Bioavailability studies across various dosage forms. Ensure strict compliance with regulatory standards (USFDA, Health Canada, WHO). Develop and review study protocols, SOPs, ICFs, and Clinical Study Reports (CSRs). Coordinate with CROs, bioanalytical labs, and internal teams for timely project execution. Interact with regulatory agencies and provide scientific responses to queries/deficiencies. Monitor regulatory trends and update internal SOPs and processes accordingly. Clinical Study Operations: Serve as Sponsors representative in assigned clinical studies, ensuring ethical and procedural compliance. Oversee dosing of study subjects , subject safety follow-ups , and ensure adherence to ICH-GCP. Review and compile raw clinical data, ensure proper monitoring and quality control (QC) . Prepare clinical updates , confinement reports , clinical summary reports , and ensure accuracy of clinical documentation. Review and finalize study documents, then hand over to QA for further processing. Support in EC submissions of protocols and related documentation. Manage study initiation , execution , archival , and retrieval of clinical records. Address and close QA/Sponsor queries and observations. Required Skills & Competencies: Deep understanding of ICH-GCP and regulatory guidelines (USFDA, CDSCO, Health Canada, WHO). Strong background in pharmacokinetics, clinical study design, and regulatory documentation. Ability to perform both strategic planning and hands-on clinical trial execution. Proficiency in clinical data handling, document management, and compliance tracking. Preferred Candidate Profile: Strong interpersonal skills and leadership qualities. Exposure to complex generics and/or challenging dosage forms is an advantage. Educational Qualifications: B.Pharm , M.Pharm , and Ph.D. in Pharmaceutical Sciences, Clinical Research, or a related field

Role & responsibilities Should perform sample processing smoothly as well as project execution with in assign time. Should handle instrument as well as QA observation. Should coordinate with Group members/ Group leader/ Lab manager Should be able to inspect raw data as per defined procedure. Should report inspection result properly. Should verify calibration record. Should maintain GLP in Lab. Preferred candidate profile 5-6 Years of Experience in Clinical Research Organizations only (Bio-Analytical Department) Qualification: MSC Immediate to 20 days joiners are preferred. You can also share your resumes on: pradnya.raut@accutestglobal.com for quicker callback

USV Biologics is looking to hire a Research Associate for their Mammalian upstream lab in Govandi, Mumbai. As a potential candidate, you should hold an M.Sc or M.Tech degree with 4-6 years of experience in mammalian upstream lab operations. Your main responsibilities will include having a comprehensive understanding of biosimilar upstream process development in mammalian (CHO expression system). You should be adept at handling CHO based cultures at shake flask level, ambr15 and ambr250 scales. Experience in process development, media feed screening, physical parameters optimization, and troubleshooting is crucial. Moreover, you should have hands-on experience in managing 5L and 50L with Multiple and Single use disposable upstream equipment, as well as process characterization and working under quality management systems. Your role will also involve the preparation of various reports related to upstream process development, thus excellent presentation and communication skills are essential for this position.,

As a Quality Analyst I at Teva Pharmaceuticals, you will be responsible for auditing each BA/BE study to ensure that facilities, personnel, equipment, instruments, protocols, methods, practice, records, and controls comply with relevant GCP/GLP guidelines, protocols, and SOPs. Your day will involve reviewing SOPs, forms, logbooks of departments, providing feedback, reviewing change control and deviations, and preparing audit reports in accordance with guidelines and regulatory inspections. You will also conduct in-process study audits to ensure compliance with GCP/GLP, protocols, SOPs, and regulatory requirements. Additionally, you will audit raw data, validation reports, bioanalytical reports, PK and statistical outputs, bio-summary tables, eCTD compilations, and collaborate with Biostatisticians and medical writers for finalization of reports. Furthermore, you will review audit trails on LC-MS/MS instruments, conduct area-specific audits, system audits, vendor audits, calibration records, and issue documents such as SOPs, protocols, and logbooks. Your role will involve ensuring compliance and adherence to quality standards in bioanalytical processes. To qualify for this role, you should have a B.Pharm, M.Pharm, or M.Sc degree with 3-6 years of experience in Bioanalytical Quality Assurance for a BA/BE Study. Join us on our mission to make good health more affordable and accessible, impacting millions of lives worldwide. Apply now to be a part of Teva Pharmaceuticals and contribute to our commitment to Equal Employment Opportunity.,

Role & responsibilities Experience Minimum 3-5 years of experience in handling ADME assays and HPLC and LCMS/MS Skills and Capabilities Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff General understanding of Drug metabolism and Pharmacokinetics Should be able to deliver scientific presentation in departmental journal club and write official Project reports Preferred candidate profile M. Pharm in Pharmaceutical sciences, Pharmaceutical Analysis who has interest and passion for LC/MS related bioanalysis.

Job Title: Invitro BA Scientist Job Location: Bangalore, Hyderabad' 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 companys 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 : • To participate in sample processing for PK, ADME assays and handling of LCMS/MS. Ability to adapt to the dynamic team environment • Processing of different matrices samples of PK studies • Optimization of test compounds manually as well as automated on LCMS/MS • Develop methods with the team lead • Independently handling of HPLC for UV based samples analysis. • Documenting the lab note books online and compound management Syngene Values All employees will consistently demonstrate alignment with our core values ' Excellence Integrity Professionalism Experience 3- 10+years Education : Msc/Pharm/Mtech/Phd/ Fresh phd with relevant exp during academics or any postdoc Skills and Capabilities • Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory • Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods • Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis • Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required • Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra • Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff • General understanding of Drug metabolism and Pharmacokinetics • Should be able to deliver scientific presentation in departmental journal club and write official Project reports

Develop, implement & maintain a robust Quality Management System (QMS) in compliance with applicable regulations (GLP, GCP, GXP, ICH guidelines) Create, review, and manage SOPs, work instructions, protocols, reports & documentation across departments Required Candidate profile 4+ years of experience in QA/QC within the pharmaceutical, biotech or drug discovery industry. Quality control certifications are preferred In depth understanding of QA/QC procedures & legal standards

Job Title: Invitro Bioanalytical Scientist Job Location: Bangalore/Hyderabad 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 companys 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 : To participate in sample processing for PK, ADME assays and handling of LCMS/MS. Ability to adapt to the dynamic team environment Processing of different matrices samples of PK studies Optimization of test compounds manually as well as automated on LCMS/MS Develop methods with the team lead Independently handling of HPLC for UV based samples analysis. Documenting the lab note books online and compound management Role Accountabilities Leadership Capabilities Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Accountabilities as a Syngene Leader (only for Leadership Hires) Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance. Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority. Specific requirements for this role 1. Experience 2. Demonstrated Capability 3. Education Experience Minimum 3-5 years of experience in handling ADME assays and HPLC and LCMS/MS Skills and Capabilities Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff General understanding of Drug metabolism and Pharmacokinetics Should be able to deliver scientific presentation in departmental journal club and write official Project reports Education M. Pharm in Pharmaceutical sciences, Pharmaceutical Analysis who has interest and passion for LC/MS related bioanalysis.

Exciting Opportunity Alert - DMPK Roles at Syngene International! Are you passionate about drug discovery and eager to contribute to cutting-edge pharmaceutical research? Join us at Syngene International for the following roles: - ADME Scientist: MSc with 6-9 years or MPharma/Mtech with 3-6 years - Sr AS: MSc with 9-12 years, MPharm/Mtech with 6-9 years - Team Lead: Fresh PhD or MSc with 15-16 years, MPharma with 12-15 years - Sr Team Lead: PhD with 3-5 years of experience - Group Lead: PhD with 5-10 years - Senior Group Lead: PhD with 10+ years Fresh PhD candidates with relevant experience during academics or postdoc are also welcome. Key Skills Required: DMPK In vitro BA and In vitro ADME Kindly note that there are no current requirements for "In vivo BA" and "In vivo PK" positions. Please share your resumes at: Sulake.Divyasree@Syngeneintl.com Core Purpose of the Role: Lead the team of bioanalysts responsible for delivering high quality data for requested ADME studies withing agreed timelines Expertise in automated discovery bioanalysis workflow practices for both small and large molecules and new drug modalities like Protacs, ADCs, Oligonucleotides etc. Updated with the latest innovations in high throughput bioanalysis, both at instruments levels and data management Sound understanding of DMPK principles and have mandatory experience in handling global clients Comprehend outcome of various in-vitro/in-vivo assays and contribute to integrated drug discovery Projects as DMPK representative

Greetings from Vivo Bio Tech Ltd! Job Responsibility: Study Director Job Title: Scientist/Senior Scientist Company: Vivo Bio Tech Ltd Location: Hyderabad Experience: 4-10 Years Education: Postgraduate (Life Sciences/Pharmacology/Toxicology or related fields) Vivo Bio Tech Ltd is seeking experienced Study Directors to lead and manage Preclinical studies in accordance with GLP and CRO regulatory guidelines . The role involves planning, execution, monitoring, and reporting of the experienced departments below: 1.Toxicology 2.Bio Analytical 3.Analytical Chemistry Job Requirements: Postgraduate degree in Life Sciences or related discipline. 4-10 years of relevant experience in Preclinical with CRO and GLP studies . Strong understanding of regulatory guidelines and data integrity practices. Excellent analytical, communication, and project management skills.

Production: Execute production batches, ensure GMP, manage documentation QA: Ensure cGMP, Issuance and retrievals and manage records. QC: Analyze biopharma samples & maintain Documentation R&D: Prepare stocks and buffers, extract proteins & analyze.

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

D organization dedicated to developing novel therapeutics, diagnostics and devices for diseases with a high socio- economic impact. Roles and Responsibilities: The key responsibility of the candidate will be to perform and analyze in vitro and in vivo DMPK studies to support drug discovery and development projects. The candidate will be involved in planning, designing and set-up of DMPK experiments, handling instruments, maintaining the laboratory and preparing and reviewing the protocol. He/ she will also be responsible for writing reports and communicating with the project team and presenting DMPK data in the project meetings. Technical Skills Ability to set up and perform physiochemical assays such as solubility and logP Experience in conducting in vitro DMPK assays, including microsomal and hepatocyte stability, plasma stability, CYP inhibition, and blood/ plasma ratio Skilled in the development and validation of bioanalytical methods across various biological matrices Experience in analysis of in-vivo pharmacokinetic samples Knowledge of sample processing techniques such as protein precipitation, liquid-liquid extraction, and solid-phase extraction Proficient in handling LC-MS/MS for quantitative analysis Experience in protocol preparation and report writing Presentation of DMPK data in scientific team meetings Additional: Experience in animal handling and conducting pharmacokinetic (PK) studies skilled in maintaining and working with cell lines such as Caco-2Ability to interpret pharmacokinetic data using Phoenix WinNonlin Experience in working in a GLP or GLP-like environment Basic Skills required Ability to work independently with enthusiasm and self-motivation Strong decision-making and problem-solving skills Effective collaboration and teamwork across multidisciplinary functions Knowledge of drug discovery and development processes Excellent oral, written, and interpersonal communication skills, with proficiency in English Proficient in computer applications including word processing, spreadsheets, and presentation tools Other Information Candidate must be an India citizen Money Salary will be commensurate with experience. Qualification M.Pharm or MS (Pharm) or PhD Experience Industry experience of 2 to 5 years

As a Research Associate/ Executive/ Analyst in the Small Molecule Bioanalytical Research Laboratory at Syngene International Ltd., you will be responsible for conducting BA/BE studies in the laboratory. Your role will involve critical method development and validation programs, ensuring technical and regulatory compliance in all studies. To excel in this position, you should have a strong background in pharmaceutics or related life sciences, along with extensive experience in the bioanalytical field, specifically in small molecule bioanalysis. Your commitment to compliance, integrity, and excellence in bioanalytical research, particularly in small molecule analysis, will be essential for success in this role. Key responsibilities include performing bioanalytical work such as sample processing for method development, method validation, and study sample analysis in compliance with SOPs and STPs. You will be required to prepare STP, MV protocol, and study sample analysis protocol, as well as coordinate with the maintenance department for any equipment failures. Documenting data generated and ensuring adherence to regulatory guidelines set by GCP/GLP will also be part of your responsibilities. To qualify for this role, you should hold a Masters in Pharmaceutics or related life sciences from a reputed university, along with a minimum of 1 year of experience in regulated small molecule bioanalysis. Hands-on experience in small molecule regulated bioanalytical experiments is crucial for this position. Additionally, having experience working in a Bioanalytical CRO lab will be considered an advantage. Core competencies required for this role include scientific expertise, technical proficiency, and strong documentation skills. You should be able to bring a creative and innovative advantage to projects, think scientifically, and conduct experiments effectively. Syngene International Ltd. is an equal opportunity employer committed to fostering a diverse and inclusive workplace. If you are interested in joining our team and contributing to cutting-edge bioanalytical research, please visit our website at https://syngeneintl.com/ for more information about our company and the work we do.,

Role & responsibilities Should perform sample processing smoothly as well as project execution with in assign time. Should handle instrument as well as QA observation. Should coordinate with Group members/ Group leader/ Lab manager Should be able to inspect raw data as per defined procedure. Should report inspection result properly. Should verify calibration record. Should maintain GLP in Lab. Preferred candidate profile 5-6 Years of Experience in Clinical Research Organizations only (Bio-Analytical Department) Qualification: MSC Immediate to 20 days joiners are preferred. You can also share your resumes on: pradnya.raut@accutestglobal.com for quicker callback