Manufacturing, Science and Technology Drug Product Lead

Location Requirement:
This position may be based on either the U.S. West Coast (ideally near San Diego, CA) or the East Coast (ideally near Raleigh, NC or Boston, MA). The role requires periodic travel between both locations to support cross‑site collaboration and business needs.

The Manufacturing, Science and Technology Drug Product Lead is responsible for:

• Subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms.   

• Oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer.    

• Lead the technical workstreams of product transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phase. 

• Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs  

• Review and supervise set up, execution and documentation of DP related technical studies (CMC development and commercial operations), process and equipment qualifications and validations.  

• Write and review applicable sections in registration files, variations and market expansion  

• Issue, review and approve applicable internal and external SOP's and external manufacturer manufacturing instructions.  

• Contribute during set up of new analytical specifications and stability programs and review changes thereof  

• Support in sourcing evaluation of new Drug product small molecules, hard-gelatine capsule based alternative contract manufacturers and participation in developing supply and quality agreements. 

• Be aware of external manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement 

• Other job related tasks