About BSV:

With over two decades of excellence, Mankind Pharma is now among India's top 5 pharmaceutical companies, powered by a 21,000 strong workforce.

For over five decades, we at Bharat Serums and Vaccines Ltd (part of Mankind Group of Companies) have used scientific resources to develop a range of biological, biotech and pharmaceutical products. We want to be a leading biopharmaceutical company driven by people and science to set benchmarks in patient outcomes across therapy areas of Women’s Health, Critical Care and Emergency Medicine.

Purpose of the role:

The Head of Cell Line Development (CLD) leads research teams to design, engineer, and characterize stable mammalian or microbial cell lines for biotherapeutic production. He/she will lead the strategy and execution of generating high-yielding, secure Chinese Hamster Ovary (CHO) cell lines. The role oversees workflows for both novel biologics (monoclonal antibodies, bispecifics, trispecifics) and biosimilars.

He/she will drive innovation in expression platforms to maximize productivity, maintain product quality, and ensure rigorous regulatory compliance from clone selection to cell banking.

Key Responsibilities:

- Platform Innovation: Direct the development of advanced mammalian expression vectors and host CHO cell lines to maximize specific productivity and product quality.
- Biosimilar Evaluation: Lead biosimilar program strategies, focusing on strict biosimilarity matching, target product profiles (TPP), and critical quality attributes (CQAs).
- Workflow Automation: Implement high-throughput automated technologies for transfection, single-cell cloning, and clone screening (e.g., Ambr system, cell sorters).
- Tech Transfer: Oversee the seamless transfer of cell lines, documentation,



and data to Upstream Process Development and manufacturing sites.
- Regulatory Compliance: Author and review CMC technical sections for regulatory filings (IND/IMPD/BLA). Ensure all cell banking processes (MCB/WCB) meet cGMP and ICH guidelines.
- Strategic Leadership: Direct global or site-specific CLD strategies from early discovery through commercialization.
- Technical Oversight: Proven expertise in CHO cell line generation, cell culture media optimization, and phenotypic characterization. Manage workflows spanning vector construction, gene editing, transfection, high-throughput clone screening, and cell banking.
- Cross-Functional Collaboration: Partner with Upstream Process Development, Analytical Development, Quality Assurance, and Regulatory teams.
- People Management: Mentor scientists, build high-performing laboratory teams, and manage department budgets and timelines.
- Innovation & Compliance: Implement next-generation expression platforms and maintain strict adherence to cGMP and safety guidelines.

Requisite for the role:

- 15 years of relevant industrial experience in Mammalian cell line development in CHO cell based platform and recombinant protein expression of high titre clones of mAbs and other therapeutic recombinant proteins.
- Biologics CMC experience, directing vector design, clone screening, scale-up, and regulatory compliance.
- PhD in Cell Biology, Biochemistry, Chemical Engineering, or Biotechnology from reputed Universities/Institutes
- Skills: Deep knowledge of mammalian expression systems (CHO cells), molecular cloning, bioreactor scale-up, and regulatory filing documentation (IND/BLA).
- Preference given to candidates with above experience who are currently based in Abroad (USA/EU) and having willingness to return to India

📌 Head of Cell Line Development (R&D) (Navi Mumbai)
🏢 Bharat Serums and Vaccines
📍 Navi Mumbai