Sr. Manager, Process Development (Sterile / Ophthalmic) – 505(b)(2) | US Market
Designation: Sr. Manager – Process Development
Department: R&D / Formulation Development
Domain: Sterile / Ophthalmic (505b2 Product Development)
Location: Gurugram
Reporting To: Head – R&D / Process Development
Role Type: Individual Contributor
Position Overview
The Sr. Manager – Process Development will lead end-to-end development of sterile and ophthalmic formulations with a strong emphasis on 505(b)(2) product development for the US Market. The role involves driving scale-up, technology transfer, process optimization, and successful regulatory submission readiness, ensuring compliance with global standards including USFDA, ICH, and cGMP.
Key Responsibilities
1. Product & Process Development
Lead formulation and process development for sterile/ophthalmic dosage forms (solutions, suspensions, emulsions, gels).
Drive 505(b)(2) product development, leveraging scientific literature, reference product evaluation, and clinical opportunities.
Design and execute DoE, robustness studies, and process capability assessments.
Develop manufacturing processes for scale-up, exhibit, PPQ, and validation batches.
2. Technology Transfer & Scale-Up
Prepare tech transfer documents and collaborate with manufacturing/production teams.
Provide on-site support during plant trials, scale-up, and exhibit batches.
Troubleshoot process-related challenges during pilot/exhibit/commercial stages.
3. Regulatory & Documentation
Prepare product development reports (PDR), process development reports (PDP), batch manufacturing records (BMR), and SOPs.
Support regulatory teams in preparing CMC sections for ANDA / 505(b)(2) submissions for the US market.
Ensure alignment with USFDA, ICH Q8/Q9/Q10, and other international guidelines.
4. Cross-Functional Collaboration
Work closely with Analytical R&D, Regulatory Affairs, Packaging Development, QA, QC, and Manufacturing teams.
Participate in project review meetings and provide scientific/technical inputs.
5. Innovation & Continuous Improvement
Identify opportunities for process optimization, cost reduction, and improvement in product performance.
Keep updated with new scientific approaches, regulatory expectations, and emerging sterile/ophthalmic technologies.
Required Qualifications & Experience
Education: M.Pharm / Ph.D. (Pharmaceutics / Pharmaceutical Technology preferred).
Experience: Minimum 13+ years in sterile/ophthalmic product development.
Mandatory exposure to 505(b)(2) development pathway for the US market.
Strong knowledge of aseptic processing, sterilization techniques, container closure systems, and compatibility studies.
Hands-on experience with autoclave, depyrogenation tunnel, FFS, BFS, filtration & filling systems.
Expertise in scale-up, troubleshooting, and commercialization of sterile/ophthalmic products.
Excellent documentation, communication, and scientific interpretation skills.
Key Competencies
Strong problem-solving and analytical abilities
Deep understanding of cGMP, FDA, ICH, and other global regulatory frameworks
Independent execution and project ownership
Technical leadership without team management (IC role)
High accountability and scientific rigor