Senior Manager/ Manager
7 hours ago
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.
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