Senior Manager/ Manager - R&D

Job Description:

Job Summary:
We are seeking an experienced and dynamic R&D Sr. Manager / Manager to lead API process development and optimization projects. The role involves overseeing laboratory research, scale-up, and tech transfer of API processes, ensuring timely delivery, compliance with regulatory standards, and alignment with business goals.

Key Responsibilities:

• Lead end-to-end API development from route scouting to scale-up and tech transfer.

• Manage and mentor a team of scientists and chemists.

• Oversee project planning, resource allocation, and execution timelines.

• Ensure adherence to cGMP, safety, and regulatory requirements.

• Review and approve technical documents, protocols, and reports.

• Collaborate with cross-functional teams including QA, QC, RA, and production.

• Support filing activities for DMF, ANDA, or other regulatory submissions.