Group Leader - API/R&D

POsition: Group Leader – R&D (API/CRO).

Department: Research & Development
Location: Mahape R & D
Reporting Manager: Head – R&D
Experience: 5–10 years
Qualification: M.Sc. / Ph.D. in Organic Chemistry, Medicinal Chemistry, or related field
Industry: API / Contract Research Organization (CRO)

Job Summary:

The Group Leader will be responsible for managing and leading a team of scientists in the development of Active Pharmaceutical Ingredients (APIs) or custom synthesis projects in a CRO environment. This role requires strong scientific, leadership, and project management skills, with a focus on quality, timelines, and regulatory compliance.

Key Responsibilities:

• Lead and manage R&D projects related to API development or custom synthesis, from lab-scale to technology transfer.
• Plan, design, and supervise synthetic routes for new and existing molecules.
• Guide and mentor junior scientists and chemists in lab operations, reaction optimization, and troubleshooting.
• Ensure compliance with regulatory standards (ICH, cGMP, GLP) and documentation practices.
• Collaborate with cross-functional teams including Analytical, QA/QC, Regulatory Affairs, and Production.
• Review and approve project reports, analytical data, and technical documentation (TDS, MoA, CoA, etc.).
• Ensure timely execution of projects within defined cost and quality parameters.
• Coordinate with clients (in CRO settings) for project updates, technical discussions, and issue resolutions.
• Support tech transfer activities to pilot plant or manufacturing scale.
• Participate in production discussion and client visits, providing technical justifications and documentation as needed.

Required Skills & Competencies:

• Strong background in synthetic organic chemistry and process development.
• Good knowledge of impurity profiling, route scouting, and scale-up techniques.
• Proficiency in interpreting analytical data (NMR, HPLC, LC-MS, GC, IR).
• Hands-on experience with lab equipment and good laboratory practices (GLP).
• Effective leadership and team management skills.
• Strong written and verbal communication skills.
• Ability to manage multiple projects and meet tight deadlines.

Preferred Experience:

• Experience in handling regulatory projects for regulated markets (US/EU).
• Prior exposure to client communications in a CRO setup.
• Knowledge of QbD principles and DoE.

Job Types: Full-time, Permanent

Pay: ₹300,000.00 - ₹1,000,000.00 per year

Benefits:

• Health insurance

Work Location: In person