General Manager - Research & Development - Active Pharmaceutical Ingredient

Job Title: General Manager (GM) / Deputy General Manager (DGM) Research & Development (API)

Department: Research & Development (API)

Location: Vadodara

Experience: 18-25 Years

Qualification: Ph.D. / M.Sc. (Organic Chemistry) with strong API Process R&D experience.

Report to: MD

Team: Around 25

Direct Reportees: 3 (Sr Managers / Managers)

Job Summary:

Lead the API Process R&D function by driving the development, optimization, scale-up, and commercialization of cost-effective, robust, and regulatory-compliant manufacturing processes for Active Pharmaceutical Ingredients (APIs). The role involves managing multiple development projects, mentoring the R&D team, and collaborating with cross-functional departments to ensure timely delivery of projects.

Key Responsibilities:

- Lead API process development from laboratory scale through pilot plant, technology transfer, and commercial manufacturing.

- Develop innovative, non-infringing, cost-effective, and scalable synthetic routes.

- Optimize processes to improve yield, quality, productivity, and manufacturing efficiency.

- Plan, review, and monitor R&D projects to meet timelines and business objectives.

- Ensure compliance with cGMP, ICH, FDA, EMA, and other global regulatory requirements.

- Review technical documents including development reports, batch records, specifications, risk assessments, and regulatory documentation (DMF/CEP support).

- Provide technical guidance during technology transfer, process validation, and commercial manufacturing.

- Investigate process-related deviations, OOS, CAPA, and implement continuous improvement initiatives.

- Collaborate with Analytical R&D, Production, QA, QC, Regulatory Affairs, Supply Chain, and EHS teams.

- Mentor and develop scientists, managers, and research associates within the R&D department.

- Evaluate new technologies, green chemistry approaches, and process intensification opportunities to enhance competitiveness.

Required Skills:

- Strong expertise in API Process R&D and scale-up.

- Thorough knowledge of synthetic organic chemistry and process optimization.

- Experience in technology transfer and commercialization.

- Hands-on knowledge of cGMP, ICH guidelines, USFDA, EDQM, PMDA, and other global regulatory expectations.

- Strong project management and people leadership skills.

- Excellent analytical, troubleshooting, communication, and decision-making abilities.

Key Performance Indicators (KPIs):

- Successful development and commercialization of API processes.

- Timely completion of R&D projects.

- Improvement in process yield and cost reduction.

- Successful technology transfers with minimal manufacturing issues.

- Regulatory inspection readiness and compliance.

- Team productivity and capability development.