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

Piramal Pharma Ltd; Hyderabad; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

Yapan Bio in Hyderabad is seeking a Head of Process Development to lead the department responsible for developing the clinical and commercial processes for novel vaccines and biologics. You will oversee upstream and downstream operations, formulation and analytical method development to ensure robust, scalable processes from early development through transfer to GMP manufacturing.

The role requires strong scientific leadership, strategic thinking, and the ability to drive cross-functional

Qualifications

• Postgraduate or PhD degree in a relevant Science or Engineering field.
• 16+ years of industry experience in mABs, gene therapy, recombinant vaccines or biologics process development.
• Experience with tech transfer and scale-up for GMP manufacturing.

Responsibilities

• Lead and manage multiple vaccine, biologics and bio-therapeutics development programs.
• Oversee upstream, downstream and analytical activities as per client/project requirements.
• Ensure processes are developed, optimized and scaled-up per quality and GMP guidelines.
• Design experiments for process development and optimization.
• Oversee planning, execution and reporting of experiments across functions.
• Manage technology transfer of processes in and out of the organization.
• Lead preparation of regulatory documentation and data presentations.
• Recruit, train and mentor team members; drive cross-functional collaboration.
• Support business development opportunities and proposals.

Skills

Leadership

People management

Cross-functional collaboration

Strategic thinking

Excellent communication

Education

Postgraduate or PhD in a relevant Science or Engineering field

Tools

Chromatography

TFF

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