The position will lead the Drug Product function, focusing mainly on establishing and coordinating sterile injectable drug product development and external CMO manufacturing activities for PMO, PPMO and Gene Therapy programs. This position will partner closely with Global Supply Chain, QA/QC, Process Development, Regulatory Affairs, and CMC teams to implement new programs and manage changes.
Primary responsibilities include:
- Leadership Responsibilities:
- Lead a team of scientists and engineers who are responsible for the entire management of drug product manufacturing partners in order to ensure product supply.
- Oversee the implementation of all drug product programs' formulation development and external CMO manufacturing strategies.
- Create, review, and approve CMC regulatory submission documentation for both clinical and commercial products.
- Drug Product Manufacturing Technical Services Provide oversight/Lead initiatives to improve overall technical and operational capabilities to match long term supply objectives
- Facilitate drug product development activities including formulation development, filtration, container closure, and extractable / leachables
- Collaborate across the organization to identify/develop new external development capabilities, and new internal drug product development capabilities
- Tech Transfer of new processes to CMOs and participating in change controls, manufacturing batch record development, IPCs, troubleshooting, and process validation
- Complete feasibility assessments of new product and technology concepts
- Drug Product External Contract Manufacturing:
- Accountable for business management of the contracts with drug product mfg. partners including establishing new or negotiating existing agreements.
- Oversight of tech transfer, validation activities, regulatory agency interactions/inspection support and routine production as necessary
- Facilitate sterile fill finish manufacturing, and release of clinical and commercial product
- Work with manufacturing partners to ensure GMP compliance are maintained with a focus on operational effectiveness and CoGs reduction initiatives
- Institute corrective actions and best practices across all fill/finish CMOs
- Prepare solicitations for competitive bids, quotations and proposals with the appropriate specifications, terms and conditions
- Manage scale-up strategy and implementation for new product introductions
- Develop tools, processes, and criteria to evaluate supplier performance
Desired Education and Skills:
- S./Ph. D in pharmaceutical sciences, organic/physical/analytical chemistry, or chemical/biochemical engineering with 15+ yrs experience and 7 years in a leadership role as an effective people manager
- Experience with sterile drug product development, as well as experience managing external contract manufacturing organizations.
- Expertise in GMP facilities and equipment design/engineering concepts
- Well-developed understanding of formulation approaches
- Strong leadership and interpersonal skills with the ability to work cross-functionally and communicate effectively across CMC functional areas
- Experience with regulations and requirements such as cGMP, ICH, USP, JP
- Domestic and international travel required
