Job Description

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 Type: Full-time

Pay: ₹500,000.00 - ₹1,000,000.00 per year

Work Location: In person