DGM​/GM; Head) Process Development - Biologics; mABs

Position: DGM/GM (Head) Process Development - Biologics (mABs)
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…