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Biocon - Senior Role - Manufacturing - Science & Technology (9-15 yrs)
Focus :
- To provide manufacturing support for drug products manufactured at Biocon's Biopharmaceuticals injectable / insulin facility at Bangalore
- Technology transfer of formulation processes from R&D to Manufacturing site and between manufacturing sites (Biocon to third party CMO, if applicable)
Primary Responsibilities :
- Responsible for monitoring, troubleshooting and improving unit operations pertaining to formulations and fill-finish
- Participate in root cause investigations (RCI) related to deviations in manufacturing process and support Quality Assurance in formalizing corrective and preventive action (CAPA)
- Support scale-up activities with R&D, clinical and commercial manufacturing (process, equipment and facility related as well as interaction with filtration service providers)
- Trending and analysis of manufacturing data (in-process) and finished product
- Support Manufacturing and QA during process validation activities
- Manage process changes with necessary documentation and provide regulatory support where appropriate
Who are we looking for :
- Pharmaceutical scientists/Pharmaceutical engineers/Chemical engineers with experience (Ph.D with 5+ years or Masters with 8+ years) in sterile manufacturing of injectables (knowledge and experience in biologics is desirable).
- The candidate must have hands on experience on process development, scale-up and technology transfer activities associated with injectables.
- Good knowledge on cGMP and associated quality management systems as well as drug delivery devices will be a definite plus.
Expectations on Specific Technical skills :
- Strong knowledge in aseptic processing (including sterile filtration principles)
- Sound knowledge on biologics
- Ability to apply statistical principles on data trending and analysis
- Working knowledge of filling lines and process related equipment/instruments
- Familiarity with current industry/regulatory trends on visual inspection procedures
Behavioral Skills :
- Strong interpersonal skills
- Excellent communication (oral and written) skills
- Decisive
- Analytical and logical thinking
- Provide practical solutions
- Mentoring of junior members
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