Sr. Manager - ADD Microbiology

2. Global Regulatory compliance, Submission & Approval Support

• Lead microbiological strategy for global filings (US, EU, Canada, Japan, Australia, China, Russia, Emerging Markets and India).
• Design and execute responses to regulatory queries (FDA and global agencies), ensuring timely approvals.
• Play a critical role in specification setting (ATP), method robustness, and validation strategy for successful submissions.
• Support for regulatory compliance through rapid troubleshooting, investigation closure (OOS/OOT), and method improvements.

3. Leadership in Method Development, Validation & Technology Transfer

• Lead high level Scientific efforts and Strategies for microbiological method development, validation, and transfers of: Drug products (Orals & Non-Orals) APIs, Peptides, excipients, and packaging materials
• Drug products (Orals & Non-Orals)
• APIs, Peptides, excipients, and packaging materials
• Innovative technical solutions in method developments through technology advancement: Optimized diluents, Neutralizers, solubilizers, pH adjustments, filtration strategies for faster method developments in complex molecules. Implementing advanced automated technologies by Rapid Microbiology Methods (RMM) for faster and
• Optimized diluents, Neutralizers, solubilizers, pH adjustments, filtration strategies for faster method developments in complex molecules.
• Implementing advanced automated technologies by Rapid Microbiology Methods (RMM) for faster and
• Seamless Technology Transfer of all validated Microbiological Methods and data at 15+ global Manufacturing Quality Control Sites & Contract Research/Manufacturing Organizations (CRO/CMO) for smooth execution of site method validations, analysis and release of reports.

4. Cross-Site Collaboration & Global Impact

• Provide strategic microbiology support to 15+ multiple sites globally (Halol, Baska, Dadra, Guwahati, Nagar, Panoli Sikkim 1, Sikkim 2, Jammu, Baddi, Dewas, Madhuranthagam - Chennai, Geotech, Haifa, Ohm Labs, Billerica, etc.).
• Enable: Inter-site method harmonization Improved method feasibility and troubleshooting capability Faster batch release and regulatory approvals
• Inter-site method harmonization
• Improved method feasibility and troubleshooting capability
• Faster batch release and regulatory approvals
• Conduct regular technical discussions with QC sites Head to understand any issues and resolve faster way.

5. Quality Systems & Compliance Leadership

• Serve as SME for Microbiology, reviewing and approvals: GSOP/GQS documents Pharmacopoeial chapters QC investigation procedures
• GSOP/GQS documents
• Pharmacopoeial chapters
• QC investigation procedures
• Lead review, approval of: SOPs, STPs, protocols, reports, and templates for scientific studies
• SOPs, STPs, protocols, reports, and templates for scientific studies
• Drive compliance through systems such as: Track Wise (Change Controls) EDMS & LMS (Document & Training Management) LIMS (Data Review, Approvals & Reporting)
• Track Wise (Change Controls)
• EDMS & LMS (Document & Training Management)
• LIMS (Data Review, Approvals & Reporting)

6. Team Development and Mentorship

• Lead, mentor and provide technical training to managers and microbiologists fostering scientific growth. Build Hands-on technical mentoring (MD/MV, troubleshooting) Supporting high-risk projects (complex oral and sterile formulations)
• Build Hands-on technical mentoring (MD/MV, troubleshooting)
• Supporting high-risk projects (complex oral and sterile formulations)
• Led interaction at R&D & training to CTA interns enhancing technical and compliance capability.

7. Strategic Resource & Infrastructure Management

• Manage long term capital expenditure (CAPEX) / assessment of instruments and laboratory resources for Microbiology Department.
• Manpower planning and recruitment for Microbiology Department

Travel Estimate

NA

Job Requirements

Educational Qualification

Qualification: M.Sc. - Microbiology

Experience

Tenure 17+ years of relevant experience

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).