Biocon - GM - Manufacturing Sciences & Technology - Drug Product Operations Function - Biologics Business (15-25 yrs)
Job description :
This is a senior leadership role in the Drug Product (DP) Operations function of Biologics Business, aimed at leading the MSAT teams to meet the business deliverables in a cGMP compliant manner.
Key Responsibilities -
- Lead the MSAT activities to achieve the business plan deliverables
- Facilitate technology transfer for new products & processes
- Author/Review CMC documents for technology transfer and global regulatory submissions
- Participate/Guide scientific investigations related to process deviations and author/review associated QMS documents
- Liaise with stakeholders to trouble shoot technical & scientific issues as needed, to achieve the business deliverables
- Identify & Implement continuous improvement opportunities in plant operations
- Foster a compliant quality culture
- Prepare and monitor the annual departmental revenue budget for Opex and Capex requirements
- Mentor and Coach direct reports
- Facilitate training & development for team members
Educational Qualification:
Qualification: PhD or Masters in science/Engineering with specialization in Biotechnology, Biochemistry, Pharmaceutical technology or Chemical engineering
Experience: minimum 15 years of Industrial experience
Technical/Functional Skills:
- Conceptually strong, drug product process development experience including tech transfer & scale up experience
- Extensive experience related to sterile Manufacturing operations
- Prior exposure to authoring/reviewing CMC dossier documentations is a must
- Prior exposure to LEAN/Six Sigma practices will be an added advantage
Leadership skills desired:
- Self-motivated and Independent, high on initiative
- Conflict management (Intra & Inter- department)
- Planning & delivery management
- Talent management & development skills
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