Head Process Development - Biologics

About the Role

This senior leadership position is responsible for steering the Process Development function for novel vaccines and biologics. The role covers a team of scientists and engineers working across early-stage process design, optimization, scale-up, technology transfer, and support for GMP manufacturing to enable human clinical trials.

The position spans upstream work such as fermentation, cell culture, and virus production, as well as downstream activities including harvest, purification, formulation, and analytical method development. It calls for a strong combination of technical depth and people leadership, with the ability to prioritize work, solve issues, and execute action plans against business objectives.

The ideal candidate will work independently, bring fresh ideas to improve efficiency and effectiveness, and regularly collaborate with cross-functional teams, senior leadership, external collaborators, and other stakeholders.

Experience

• At least 18 years of relevant industry experience in monoclonal antibodies, gene therapy, recombinant vaccines, and/or biologics process development.
• Hands-on exposure to vaccines and biologics unit operations, including adherent and suspension cell culture, harvest, downstream processing such as chromatography and TFF, formulation, and analytical methods.
• Proven experience in technology transfer and in building processes and technologies for robust scale-up and GMP manufacturing.
• Prior involvement in developing bioprocesses from the early stages for novel molecules such as vaccine antigens or biologics is strongly preferred.

Key Responsibilities

• Direct and oversee several vaccine, biologics, and biotherapeutics development programs.
• Manage upstream, downstream, and analytical development work according to client needs.
• Make sure processes are developed, optimized, and scaled in line with project needs and applicable quality, regulatory, and GMP expectations.
• Plan and design experiments for process development and optimization based on project objectives.
• Supervise the daily execution of experiments and coordinate activities across functions within the department.
• Track reports, records, and documentation related to process development work.
• Lead technology transfer activities both into and out of the organization.
• Ensure projects are executed in line with the company’s quality policy.
• Confirm that teams maintain equipment and facilities in accordance with organizational quality systems.
• Contribute to CMC sections of regulatory submissions, including INDs and responses to regulatory questions.
• Ensure the right people, equipment, and materials are available to meet timelines and budgets.
• Review and support the preparation of data, reports, and documents for experiments and client requirements.
• Interact regularly with clients and senior management, including presenting data and project updates in required formats.
• Coach team members and guide them toward delivery aligned with corporate goals, plans, and milestones.
• Hire, train, develop, and mentor team members.
• Help identify new business opportunities and contribute to proposals, timelines, and budgets for new projects.
• Represent the Process Development function internally and externally.
• Prepare and manage departmental operating plans and budgets.
• Create a safe, collaborative, and high-performance team environment.
• Maintain open communication and uphold strong standards of ethics, quality, and integrity.

Additional Information

This opportunity is based in Hyderabad, India. The role involves leading a department focused on clinical and commercial process development for biologics and vaccines within a CDMO environment. The source did not specify openings, salary, perks, eligibility, or start date.