Biocon - Senior Role - Manufacturing - Science & Technology

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