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

Piramal Pharma Ltd; Hyderabad; On-site; INR 2,800,000 - 5,200,000; Full time

Job summary

Yapan Bio is seeking a seasoned Head of Process Development to lead the department responsible for advancing clinical and commercial bioprocesses for vaccines and biologics. You will oversee upstream/downstream/analytical activities, drive scale-up and technology transfer, and coordinate with senior management and clients to meet timelines and budgets.

The role requires 16+ years in vaccine/biologics development, a postgraduate or PhD in a relevant field, and demonstrated leadership across

Qualifications

• Postgraduate or PhD in a relevant science or engineering field.
• 16+ years in mABs, gene therapy, vaccines or biologics process development.
• Experience with vaccines/biologics processes, including cell culture, harvest, chromatography and TFF.
• Experience with technology transfer and GMP manufacturing operations.
• Experience in developing bioprocesses for novel molecules (vaccine antigens or biologics) is desirable.

Responsibilities

• Lead, direct and manage multiple vaccine, biologics and bio-therapeutics development programs.
• Lead and manage development programs involving upstream, downstream and analytical activities as per client requirements.
• Ensure processes are developed, optimized and scaled-up per quality, regulatory and GMP guidelines.
• Design experiments for process development and optimization for project goals.
• Oversee planning and execution of experiments and integrate across functions in process development.
• Manage planning, execution, and tracking of reports and documents related to process development.
• Oversee/manage technology transfer of processes in and out of the organization.
• Work and drive programs in line with the company's Quality policy.
• Ensure teams maintain equipment and facilities per quality systems.
• Lead preparation of CMC sections of regulatory filings (INDs, responses, etc.).
• Ensure resources are available to deliver projects on time and within budget.
• Prepare data, reports and documents for conducted experiments and client requirements.
• Engage with clients and senior management, presenting data and reports regularly.
• Guide and develop team members to meet corporate goals and timelines.
• Recruit, train, and mentor team members.
• Support identification of new business opportunities and proposals.
• Represent the Process Development team internally and externally.
• Prepare and manage department operating plans and budget.
• Foster a safe, collaborative culture and high ethics, quality and integrity.

Education

Postgraduate or PhD degree in a relevant Science or Engineering field

Job description

Yapan Bio is a Biotechnology Company established to serve the rapidly expanding Custom Development and Manufacturing (CDMO) market for Vaccines and Biologics/Bio-therapeutics. Yapan Bio has established state-of-the‑art facilities for process development and GMP manufacturing for human clinical studies, including both Drug Substance (DS) and Drug Product (DP), at Genome Valley in Hyderabad. The facility is built as per the quality and regulatory expectation of the global regulatory authorities. The facility includes Bio-Safety Level 2+ (BSL-2+) suite to develop and manufacture high containment product classes. Yapan Bio is currently developing novel vaccines and biologics for the global innovative biotechnology companies.

We are looking for talented and experienced individuals, with can- do attitude, who are self-starters with excellent communications & leadership skills, who enjoy working on the details without losing sight of the larger organizational goals and are adaptable to a dynamic “startup” environment, to join our team. At Yapan Bio, you will get a supportive, collaborative, and empowering work environment to make a significant impact along with ownership as we drive the growth of the company together.

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.

REPORTING STRUCTURE

Will report to Site Head Biologics

QUALIFICATION

Postgraduate or PhD degree in a relevant Science or Engineering field

EXPERIENCE

• 16 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 department’s 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