Head of Cell Line Development (R&D)

Bharat Serums and Vaccines Limited; Navi Mumbai; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Bharat Serums and Vaccines Ltd, part of the Mankind Group, seeks a Head of Cell Line Development to lead CHO cell line design and high-throughput workflows for biotherapeutics. The role drives innovation in expression platforms, ensures cGMP compliance, and coordinates with QA, Regulatory, and Upstream teams.

The position requires 15+ years in mammalian cell line development, a PhD, and strong leadership with global/IND regulatory exposure. Based in Navi Mumbai, India.

Qualifications

• 15+ years of industrial experience in Mammalian cell line development on CHO platforms.
• Biologics CMC experience including vector design, clone screening, scale-up, regulatory filing (IND/BLA).
• PhD in a relevant field from a reputed institute.

Responsibilities

• Direct development of CHO cell lines to maximize titre and product quality.
• Lead biosimilar program strategies focusing on biosimilarity, TPP, and CQAs.
• Implement high-throughput automated workflows for transfection, single-cell cloning, and clone screening (Ambr system, cell sorters).
• Oversee tech transfer of cell lines, documentation, and data to Upstream Process Development and manufacturing sites.
• Ensure all cell banking processes meet cGMP/ICH guidelines and regulatory filings.
• Direct global or site-specific CLD strategies from discovery through commercialization.
• Mentor scientists, build lab teams, and manage budgets/timelines.

Skills

CHO cell line development

Mammalian expression systems

Cell culture optimization

Gene editing

Biologics development

Education

PhD in Cell Biology

Tools

Ambr system

Flow cytometer

Bioreactor scale-up

Job description

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, stable 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