Analytical Development Scientist (Non PhD)
Roles & Responsibilities
- Execution of experiments for analytical method development/qualification/transfer, in-process/stability sample testing, biosimilarity analysis and evaluation of new high‑throughput formats of testing using chromatography (HPLC/UPLC), electrophoresis/capillary electrophoresis, UV spectrophotometer, Solo‑VPE and other high‑end analytical tools.
- Sample analysis in GC, Atomic Absorption Spectroscopy (AAS), Charged Aerosol Detector (CAD), glycan analysis, etc.
- Sequential and logical planning of experiments.
- Record experiment details (procedure, controls, analyses and observations) accurately and completely following good documentation practices in an electronic laboratory notebook.
- Compilation, interpretation and communication of experimental data to cross‑functional teams, preparation of reports and participation in internal group meetings.
- Prepare method development reports, protocols, instrument operation procedures, author change controls and deviations.
- Perform literature survey of assays, support experimental design based on historical data and troubleshoot experiments.
- Maintain equipment and instruments in coordination with the instrumentation team, support installation of new equipment, and prepare instrument operating procedures.
- Track inventory of consumables and critical reagents, ensure timely ordering, and follow up on ordered materials.
- Participate in QMS related activities.
Education
- Degree in life sciences such as biology, biochemistry, biotechnology, analytical chemistry or a closely related field.
- M.Pharma/M.Sc/M.Tech with 3–8 years of research experience.
Required Experience
- Experience in leading biopharmaceutical organizations, contributing to high‑impact research and development initiatives.
- Strong expertise in chromatographic techniques including Ion Exchange (IEC), Reverse Phase (RP), Size Exclusion (SEC) and Hydrophilic Interaction Chromatography (HILIC) for protein therapeutics, and glycan analysis.
- Additional experience in excipient analysis using ELSD, CAD and MS platforms is highly valued.
- Hands‑on experience with a wide range of analytical instruments such as HPLC, UPLC, Capillary Electrophoresis (CE), UV‑Vis Spectrophotometer, Solo‑VPE, Octet, Maurice, GC, AAS, etc.
- Higher‑order structure analysis techniques (CD spectroscopy, DSC, DLS, SEC‑MALS, FTIR).
- Demonstrated ability to contribute to experimental design and troubleshooting within collaborative, cross‑functional team environments.
- Skilled in data analysis using instrument‑specific software and working knowledge of statistical tools for method evaluation and interpretation.
- Thorough understanding of regulatory guidelines including ICH, WHO and USP for method development, qualification, transfer and validation.
- Proficiency in electronic laboratory notebook (eLN) systems is also preferred.
- Effective communication and teamwork, capable of articulating scientific concepts, challenges and solutions clearly.
- Familiarity with Empower Method Validation Manager is an added advantage.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function and Industries
Research, Science and Health Care Provider; Biotechnology Research; Pharmaceutical Manufacturing; Medical Equipment Manufacturing.