Posted:19 hours ago|
Platform:
Work from Office
Full Time
We are seeking a highly skilled and motivated Drug Product Development Scientist to join our dynamic team focused on developing biologic drug products. The ideal candidate will have extensive experience in the formulation, development, and scale-up of biologic drug products, such as monoclonal antibodies, vaccines, and gene therapies. The Ideal candidate would have: 5+ years of experience in drug product development preferably in the Biologics space. Candidate is expected to have hands on experience (not limited to) on analytical techniques like, HPLC, UPLC, Lyo, Karl Fischer, Solo VPE, MFI etc. Stability study: designing, protocol drafting, data evaluation and reporting Process related documents like FMEA, risk assessments, process characterization. specifications, TTD, etc. Basic idea of various regulatory filing and their requirements Understanding on filter validation Good communication skill (writing and verbal) Attitude to collaborate Required Qualifications: Education & Experience : BS/MS degree in Pharmaceutical Sciences, Biotechnology, Biochemistry, Chemical Engineering, or related field. experience in drug product development for biologics (e.g., monoclonal antibodies, vaccines, gene therapies). Strong knowledge of formulation science, particularly in biologic drug products (injectable solutions, lyophilized products, etc.). Experience in GMP (Good Manufacturing Practices) and regulatory compliance for biologics. Hands-on experience with bioreactor operations, protein purification, and bioprocessing techniques is highly desirable.
Biocon Biologics Limited
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