Biocon Biologics, a leading company in the biosimilars sector, is committed to making healthcare affordable for all. With a focus on biosimilars, Biocon Biologics is at the forefront of revolutionizing the industry by ensuring high-quality products reach patients worldwide. The company is driven by a vision of affordable innovation and patient-centric solutions, aiming to impact a billion lives. Biocon Biologics has end-to-end expertise in biosimilars, including development, manufacturing, clinical development, regulatory approvals, and commercialization.
Responsibilities in the Job
As part of the Cell Culture Lab – Upstream R&D role, the selected candidate will take on several key responsibilities:
- Technical Leadership: Lead teams in cell culture for robust process development and technology transfer, ensuring timely completion of project goals.
- Team Management: Accountable for hiring, training, and building a skilled cell culture team while ensuring adherence to compliance and organizational requirements.
- Lab Operations Management: Oversee inventory management, equipment handling, and project budgets for seamless operations.
- Collaboration Across Teams: Work with cross-functional teams to manage cell culture operations, contributing to the development and transfer of new processes.
- Risk Management & Process Characterization: Apply risk management strategies and work on scale-up, scale-down models, and process characterization.
- Documentation: Ensure compliance with ALCOA principles by adhering to robust documentation practices and preparing technical documents for senior management.
- Regulatory Support: Provide necessary support for regulatory dossier preparation, filing, reviews, and audits.
- Statistical Analysis: Utilize statistical tools and data analysis for continuous process improvement.
Qualifications
The ideal candidate should have:
- Educational Requirements: A relevant degree in Biotechnology, Biochemical Engineering, or a related field.
- Experience: Extensive experience in upstream processes, particularly in cell culture operations, process development, scale-up, and tech transfer. Experience with managing lab operations and working cross-functionally is preferred.
- Technical Expertise: Familiarity with risk management strategies, process characterization, and statistical tools for data analysis.
- Leadership Skills: Proven ability to lead and build teams, and manage projects to ensure timely and successful outcomes.
- Regulatory Knowledge: Understanding of regulatory requirements and experience with regulatory dossier preparation and audits.
Skills Required
- Technical Expertise: Process development, scale-up, tech transfer, and process characterization.
- Team Leadership: Experience in hiring, training, and building high-performing teams.
- Cross-Functional Collaboration: Ability to work seamlessly with manufacturing, MSAT, Quality, and regulatory teams.
- Statistical & Data Analysis: Skilled in using statistical tools for data analysis and process improvement.
- Documentation: Strong knowledge of ALCOA principles and documentation practices.
