Bioanalytical methods and Analysis of study samples of animal and human origin: Develop bioanalytical methods for New Chemical entities, drugs, metabolites in different biological matrices ELISA/MSD. Perform Method validation and sample analysis.
Study Sample accountability: Responsible for accountability of study and stability samples from date of receipt till disposal.
SOP and trainings: Understand SOPs and procedures
Commitment to Quality: Ensure activities conducted in the bioanalytical lab complies with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures.
Documentation accountability of Study / Method Validation file: Checking of data accuracy and integrity, data collation and report preparation.
Calibration and Maintenance of Instrument: Able to perform calibrations and maintenance of small and major equipment.
Routine procedures and systems checks: Review general documents, log books, calibration records required in assuring GLP compliance and report findings to supervisor.
Document management: Ensure safe custody of study and method validation files and their archival as per established procedure.
Responsibilities allotted by Supervisor
Desired Candidate Profile
MSc/M.Pharm in Pharmacy, Biochemistry, Protein Chemistry, Analytical Biochemistry, Chemistry, Analytical Chemistry or related area required. 1-3 Years of relevant work experience in a research and/or development environment is required.
Hands on experience to operate instruments like ELISA, MSD to quantify drugs and their metabolites in biological matrices.
Hands on with routine instruments like pH meters, weighing balances, centrifuges, shakers, single and multichannel pipettes and Milli Q system, Auto-washers,
Ability to develop efficient and robust bioanalytical methods.
Hands on experience with sample preparation of large molecules using LBA platform.
Knowledge of Good Laboratory Practices (GLP) procedures and bioanalysis related guidance documents on OECD and USFDA, EMA
Familiarization with computer is essential (MS word, MS Excel, Power point)
Must be willing to work as part of a team and should have good Well versed with good interpersonal skills, presentation and communication skill
Ability to review experimental data, SOPs, procedures, reports. The hands on experience with electronic data management
Handling of LIMS software will be considered an added advantage.
Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates.Company Info
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