Precision Life Sciences
Sr Manager/Associate Director of Technical Operations, Drug Substance
The Sr Manager/Associate Director of Technical Operations, Drug Substance ensures the drug substance supply for approved small molecule therapy. This role collaborates closely with QA, regulatory, and compliance teams, supporting commercial drug supply and is involved in supplying drug substance to a partner for potential ocular/ophthalmic use. The Sr Manager/Associate Director of Technical Operations oversees new process implementation and scale-up, manages data review, CMO relationships, and technical aspects of substance development.
- Reviews data and provides support for the process development at the CMO.
- Manages process re-validation at the CMO.
- Works with contract analytical laboratories to provide in-process support to drive PD efforts and engineering runs for process modification.
- Assure that final drug substance achieves a level of purity sufficient for collaborating partner CMO.
- Working with management and the CMO to generate technical protocols, reports and batch records to support the cGMP manufacture of drug substance.
- Assists in Defining project timelines to support registrations.
- Communicates clearly, efficiently and accurately with internal team members and external partners.
- Fully experienced with cGMPs and all applicable regulations and guidance.
- Strong technical aptitude including the demonstrated experience of developing and supporting the life-cycle management of synthetic processes.
- Must be a self-motivated, highly organized and personable individual capable of seeing tasks through influence of external partners.
- PhD in a field such as Organic/Medicinal Chemistry or Chemical Engineering, with a specialization in the manufacturing science of small molecules.
- A minimum of five years of hands-on development and/or commercial industry experience in the manufacturing science of synthetic small molecules.
- Experience in interacting with external partners and contract manufacturing organizations required.
- Experience in collaborating with process development, QC/AD and supply chain/logistics functions in assuring supply of necessary components to assure drug substance timelines are met.
- Experience in managing and oversight of failure investigations, development of reports and protocols.
- Thorough knowledge of production cGMPs and interactions with Regulatory Authorities.
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