Research Scientist - Bioassay and Immunogenicity Studies

Research Scientist

Job Description

Key skills: Bioassay, Cell culture, Statistical data analysis, Immunogenicity studies (both innate & Adaptive immunogenicity studies), Pharma experience

Primary responsibilities for Bioassay:

· Manage the development of biological assays, including method development, method validation, and sameness analysis of complex, injectable drug products (following GLP and GMP guidelines) for regulatory submission and subsequent response to queries from regulatory bodies

· Coordinate with third-party contract testing labs to conduct sameness studies of complex injectable products. In parallel, assist in the development of in-house capabilities to perform bioanalytical and biological characterization of injectable drug products

· Sample management for studies performed at third-party contract labs, including sample shipment, coordination with purchase team for handling quotations, PR, PO, invoicing, etc. and maintaining updated records for the same

· Handle a team of scientists by providing guidance & training on method development, routine analysis, instrument qualification and calibration activities etc.

· Design, preparate and review protocols, reports, SOPs, STPs, and other documents required in the characterization of complex injectables at in-house laboratories and third-party contract labs

· Maintain compliance with all lab practices and documentation as per Good Laboratory Practices (GLP) and data integrity norms

· In addition, must have previous hands on expertise in sterile handling of mammalian cell-culture (both adherent and suspension cell line) for cell bank (MCB & WCB) preparation and qualification for bioassay.

· Plan and if required execute various in-vitro assays, such as GPCR cAMP cell-based assay, cell proliferation inhibition assay, receptor binding assays and other cell-based assays to evaluate functional properties of Drug substance or Drug Product.

· Must have the ability to analyze and interpret result by statistical analysis, draw conclusion and compile data for reporting the similarity assessment of the test sample and reference product.

· Testing of mycoplasma contamination

· Multi-mode plate reader handling with either Gen5 or SoftMax pro software

· Knowledge of PLA 3.0 software

Primary responsibilities for Immunogenicity studies:

· Oversee immunogenicity studies of injectable drug products, including in-silico, innate and adaptive immune responses to meet regulatory requirements and query responses

· Knowledge of Flow cytometry data analysis

· Must have the ability to analyze and interpret result by statistical analysis, draw conclusion and compile data for reporting the similarity assessment of the test sample and reference product

Desirable:

· Handling of serum-free mammalian cell culture

· Handling of Flow cytometry

Work Experience

10yrs or PhD with more than 6 years

Education

Masters in Biotechnology or Science

Competencies

1. Strategic Agility2. Innovation & Creativity3. Customer Centricity4. Developing Talent5. Result Orientation6. Process Excellence7. Collaboration8. Stakeholder Management