Biocon Biologics is a fully-integrated ‘pure play’ biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe.
The candidate will work closely with internal and external stakeholders to ensure the successful technology transfer of the biologic drug products processes.
The role requires working with different project teams on early and late-stage development within R&D for successful scale-up and Technology Transfer stages.
Key Responsibilities
- Lead the technology transfer for the Drug Product processes from development to manufacturing scale.
- Work closely with the development teams to advise on facility fit experiments to ensure that processes are scalable, robust, and meet global regulatory requirements.
- Work closely with internal stakeholders, including R&D teams in the Process, Analytical & Device Development, and manufacturing, to ensure successful technology transfer of drug product processes.
- Work closely with the Data Sciences team for building simulation and modelling tools wherever applicable for the Drug Product function.
- Build knowledge in the field of Extractables & Leachables, sub-visible particles etc.
Behavioural / Management / Other Skills:
- Ability to make decisions, appropriately balancing risks versus impact.
- Strong leadership skills, able to get the buy-in of multiple stakeholders.
- Ability to work under pressure and cope with multiple priorities.
- Ability to drive change throughout an organization, overcoming resistance and barriers.
- Outstanding communication of information and ideas, both written and verbal, to diverse audiences.
Background & Experience Required
The Technology Transfer Lead for Drug Products in Biocon Biologics R&D will be responsible for leading the Scale-up of drug product processes from development to manufacturing.
- Minimum of 12 years of experience for Ph.D. or 16 years of experience or more for M. Tech candidates in technology transfer of drug product processes in biologics, with demonstrated experience in the successful approval and commercialization of biologic drug products.
- Candidate should have good understanding of challenges during technology transfer of filling lines for vials, PFS, cartridges etc.
- Strong technical expertise in drug product development, including a deep understanding of process development, analytical development, and regulatory requirements.