Biocon - GM - Manufacturing Sciences & Technology - Drug Product Operations Function - Biologics Business

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