About the job
Location Requirement:
This position can be located on either the U.S. West Coast (preferred near San Diego, CA) or the East Coast (preferably near Raleigh, NC or Boston, MA). The role involves occasional travel between both locations to facilitate cross-site collaboration and meet business objectives.
The Drug Product Lead in Manufacturing, Science and Technology is accountable for:
Acting as the subject matter expert (SME) and process owner for the manufacturing of drug products (DP) utilizing small molecules in non-sterile dosage forms.
Managing all technical aspects of drug product manufacturing under Good Manufacturing Practices (GMP) for small molecules produced by external manufacturers.
Leading technical workstreams for product transfers from development to commercial sites, including scale-up activities, process validations, and overseeing the manufacturing of drug products at external manufacturers during clinical and commercial phases.
Coordinating internal activities related to external manufacturing, including process change assessments, managing major/critical deviations, conducting risk assessments, and overseeing Corrective and Preventive Actions (CAPAs).
Reviewing and supervising the setup, execution, and documentation of DP-related technical studies (CMC development and commercial operations), as well as process and equipment qualifications and validations.
Drafting and reviewing relevant sections in registration files, variations, and market expansion submissions.
Issuing, reviewing, and approving internal and external Standard Operating Procedures (SOPs) and manufacturing instructions from external manufacturers.
Contributing to the establishment of new analytical specifications and stability programs, and reviewing any changes.
Assisting in the evaluation of new drug product small molecules, identifying alternative contract manufacturers for hard-gelatine capsules, and participating in the development of supply and quality agreements.
Staying informed about advancements in external manufacturing technologies, understanding and introducing new technologies that could enhance process innovation, cost, or yield improvements.
Performing other job-related tasks as assigned.