Vacancy description

Analytical R&D Head- Biologics in भारत

Talental Consultings

  • Full-timeStandard weekly hours

भारत

Designation: DGM / GM
Industry: Biologics / Biosimilars / Biotechnology

Role Objective

To lead Analytical Research & Development, including Analytical Method Development, Characterization and Bioassay Development for biologics, biosimilars and recombinant therapeutic proteins across the product development lifecycle.

Key Responsibilities

  • Lead the ARD function covering Analytical Development, Analytical Characterization, Method Development, Validation and Bioassay Development.

  • Drive analytical method development, optimization, qualification and validation for Drug Substance (DS) and Drug Product (DP).

  • Lead physicochemical, structural and functional characterization of biologics, including monoclonal antibodies (mAbs), biosimilars and recombinant proteins.

  • Establish analytical strategies for biosimilar development, comparability studies and characterization of Critical Quality Attributes (CQAs).

  • Lead development, optimization and validation of cell-based and ligand-binding bioassays for potency and biological activity assessment.

  • Oversee functional characterization, including receptor binding, binding affinity, biological activity and mechanism-of-action-related assays.

  • Ensure development of robust bioassays for potency determination, including cell-based assays, ELISA and other immunological assays.

Key Analytical Techniques

  • HPLC / UPLC – SEC, RP-HPLC, IEX and HIC.

  • LC-MS / Mass Spectrometry and Peptide Mapping.

  • CE-SDS, SDS-PAGE and Western Blot.

  • Glycan / Glycosylation Analysis.

  • Amino Acid Analysis and Charge Variant Analysis.

  • UV, FTIR, Circular Dichroism and other structural characterization techniques.

  • Aggregation, Purity and Impurity Profiling.

  • Forced Degradation and Stability Studies.

Bioassay & Functional Characterization

  • Cell-based potency assays and functional bioassays.

  • ELISA and ligand-binding assays.

  • Receptor binding and binding affinity studies.

  • ADCC, CDC and ADCP assays, wherever applicable.

  • Signal transduction and mechanism-of-action-based assays.

  • Relative potency determination and biological activity assessment.

  • Bioassay development, qualification, validation and transfer.

Candidate Profile

  • Ph.D. / https://jobeax.com/link/g8jPrtYeTViWKuvF / M.Sc. in Analytical Chemistry, Biochemistry, Biotechnology, Life Sciences or related discipline.

  • 15–20+ years of experience in Analytical R&D within biologics / biosimilars / biotechnology.

  • Strong experience in both Analytical Characterization and Bioassay Development .

  • Hands-on and leadership experience in characterization of monoclonal antibodies, biosimilars and recombinant therapeutic proteins.

  • Experience in developing and validating cell-based potency assays and ligand-binding assays.

  • Strong understanding of ICH guidelines, global regulatory requirements and biologics CMC.

  • Experience in leading analytical and bioassay teams and managing cross-functional development projects.

Preferred Experience

  • Experience in USFDA / EMA-regulated biologics or biosimilar product development.

  • Exposure to analytical similarity assessment, comparability studies and regulatory submissions.

  • Experience in establishing and scaling up Analytical R&D and Bioassay laboratories.

 

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