At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Provide end-to-end leadership for microbiology method development, pre-validation, and lifecycle management across all types of Formulations - Orals, Non-orals, API, Peptides, Excipients, Packaging Materials etc.
Lead for innovative development of regular and complex range of products e.g. Solution Injection, Injectable Suspension, RTU Bag, Nano particles, Lyophilized products, Liposome injections, Antibiotic Injections, Ophthalmic, Transdermal patch, Metered Dose Inhalers, Nebulizers, Nasal Spray, Nanosuspension, Dry Powder Inhaler, Microsphere, Implants, Topical gel, Cream, Patches, Branded products, Tablets, Capsules, Liquids, suspensions etc.
Lead the strategy for development, optimization, scale-up and exhibit of microbiological methods from laboratory benchmark to commercial manufacturing in various range of products e.g.
Successfully managed the R&D Microbiology Lab for ensuring seamless operations, governance and compliance.
Drive execution excellence by aligning cross-functional teams (QA, QC, FRD, RA, Manufacturing) toward accelerated development timelines.
Don't want to miss the next one?
Subscribe to daily email alerts for roles matching your interests.
Ensure adherence to GLP/cGMP standards, strengthening FDA inspection readiness and audit compliance across sites.
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.
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
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
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.
Supporting high-risk projects (complex oral and sterile formulations)
Led interaction at R&D & training to CTA interns enhancing technical and compliance capability.
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).
Similar roles you might like
More openings like this one — take a look before you go.
