DGM/GM (Head) Process Development - Biologics (Yapan)

JOB OVERVIEW:

The incumbent will be responsible for leading the Process Development department comprising of scientists and engineers responsible for developing the clinical/commercial process(es) for novel vaccines and biologics products from early-stage process development & optimization, and scale-up to supporting Technology Transfer and GMP manufacturing activities for human clinical trials.

The Head Process Development will be responsible for upstream (fermentation, cell culture, virus production etc.) and downstream (harvest & purification) activities along with formulation and analytical method development.

This position requires demonstrated ability to work effectively as both scientific/technical and people leader, manage tasks, resolve problems and issues and drive implementation/action plans to meet objectives along with excellent interpersonal and presentation skills.

The candidate should be self- sufficient in planning and execution along with applying innovative thinking to improve effectiveness and efficiency of the function. A person in this role is expected to engage and interact frequently with cross functional teams, senior management, external partners/collaborators, and stakeholders.

EXPERIENCE:

• 18 plus years of relevant industry experience in maBs, gene therapy , recombinant vaccines and/or biologics process development
• Practical experience with vaccines and biologics processes/unit operations, including adherent and suspension cell culture, harvest, downstream process (Chromatography, TFF etc), formulation and analytical methods etc.
• Experience with technology transfer and development of processes and technologies for robust scale-up and GMP manufacturing operations
• Experience of developing bioprocesses from early stages of development for novel molecules (vaccine antigens or biologics) is highly desirable

Key Roles/Responsibilities

• Lead, direct and manage multiple vaccine, biologics and bio-therapeutics development programs
• Lead and manage multiple vaccines, biologics and bio-therapeutic development programs involving upstream, downstream and analytical activities as per the client requirements
• Ensure the processes are developed, optimized and scaled-up as per the client/project requirements adhering to relevant quality, regulatory and GMP expectations/guidelines
• Design experiments for process development and optimization as per the requirements of the relevant project goals
• Oversee the planning and execution of the relevant experiments and activities on a day-to-day basis including integration of the same across different functions within the process development department
• Manage planning, execution, and tracking of relevant reports and documents related to process development
• Oversee/manage technology transfer of processes both in and out of the organization
• Work and drive programs in accordance with Quality policy of the company.
• Ensure that the teams maintain the equipment & facilities as per the expectations and Quality systems of the organization
• Lead preparation of specific CMC sections of regulatory filings (including INDs, responses to regulatory inquiries etc.)
• Ensure appropriate resources (people/equipment/material etc.) are available and engaged to deliver projects as per the agreed timelines and budgets
• Ensure appropriate data compilation and reports/document preparation for conducted experiments and as per the client/project requirements
• Engagement and interactions with the clients and senior management including preparation and presentation of data, reports and documents in the relevant formats regularly
• Guide and lead members of the team to deliver as per the corporate goals, projects, plans and timelines.
• Recruit, train, grow and mentor members of the team
• Support identification of new business opportunities and preparation of proposals for the new projects including developmental activities, timelines and budget
• Represent the Process Development team both internally and externally
• Prepare and manage departments operating plans and budget
• Foster a safe and collaborative culture and work environment to ensure the team works together to reach their potential
• Communicate openly and work to the highest levels of ethics, quality and integrity