About the job
Location Requirement:
This position can be located on either the U.S. West Coast (preferably 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 collaboration and meet business requirements.
The Drug Product Lead for Manufacturing, Science and Technology is accountable for the following:
Acting as a subject matter expert (SME) and process owner for the manufacturing of Drug Products (DP) involving small molecules in non-sterile dosage forms.
Overseeing all technical aspects of drug product manufacturing under Good Manufacturing Practices (GMP) for small molecules produced at external manufacturing sites.
Leading technical workstreams for product transfers from development to commercial sites, scale-up activities, and process validations while supervising the manufacturing of Drug Products for clinical and commercial projects.
Managing internal activities related to external manufacturing, including process change assessments, critical deviations, risk assessments, and 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.
Writing and reviewing relevant sections in registration files, variations, and market expansion documents.
Issuing, reviewing, and approving internal and external standard operating procedures (SOPs) and manufacturing instructions from external manufacturers.
Assisting in the establishment of new analytical specifications and stability programs and reviewing any changes.
Supporting the evaluation of new small molecule drug product manufacturers, hard-gelatine capsule-based contract manufacturers, and participating in the development of supply and quality agreements.
Keeping abreast of advancements in external manufacturing technologies, understanding, and implementing new technologies that could lead to process innovation, cost efficiency, or yield enhancement.
Performing other job-related tasks as necessary.