Biocon Biologics is a global leader in biosimilars, committed to delivering high-quality, affordable biologics to patients worldwide. As a subsidiary of Biocon, the company focuses on innovation in biopharmaceuticals, with a strong emphasis on research and development (R&D), manufacturing, and commercialization of biosimilar products.
With state-of-the-art facilities and a team of industry experts, Biocon Biologics is at the forefront of advancing drug product development, ensuring cutting-edge solutions for complex therapeutic challenges.
Job Description: R&D Drug Product Development
Key Responsibilities:
- Conduct and support formulation development for biologics and injectables.
- Manage cross-functional interactions with Operations, Quality, Production, and MSAT teams.
- Prepare technical documents, including stability protocols, reports, and technology transfer documents.
- Plan and execute stability studies, analyze samples, and interpret results.
- Use analytical instruments like HPLC (SEC, IEX, RP), UPLC, CE-SDS, UV spectrometry, Solo-VPE, Osmometer, and KF moisture analyzer.
- Maintain Good Documentation Practices (GDP) and ensure compliance with regulatory standards.
- Prepare and review protocols, risk assessments, and Manufacturing Formula Cards (MFC).
- Present experimental outcomes in a structured manner to stakeholders.
Required Skills & Qualifications:
- Education: MS/MTech in a relevant field with Drug Product MSAT knowledge.
- Experience: Minimum 7 years in drug product development, preferably in biologics.
- Technical Skills:
- Proficiency in HPLC, UPLC, CE-SDS, and other analytical techniques.
- Experience with statistical software (JMP, Minitab), eLN, and Empower.
- Strong knowledge of MS Office (Excel, PowerPoint, Word).
- Soft Skills: Strong analytical thinking, problem-solving, and teamwork abilities.
Why Join Biocon Biologics?
- Work with a globally recognized leader in biosimilars.
- Opportunity to contribute to innovative drug development projects.
- Collaborative work environment with industry experts.
- Career growth and professional development opportunities.
