The Director, Oral Product Development is responsible for building and leading a vertically integrated team of scientists/engineers responsible for the development and manufacture of oral drug products. This position is integral to the advancement of TESARO’s growing portfolio of pharmaceutical drug candidates and technology programs, and will provide technical oversight and strategic guidance for all oral drug product activities. The scope of the role encompasses the full breadth of the drug development lifecycle, ranging from the drug discovery/early development interface through technical transfer to commercial manufacturing operations and subsequent process validation. It extends further to the preparation of CMC content for regulatory (e.g. NDA/MAA) submissions and technical support (e.g., troubleshooting, process improvement, changes in manufacturing site and/or scale, etc.) for all in-market oral drug products following regulatory approval.
In accordance with TESARO’s virtual (100% outsourcing) model for drug development, the incumbent will oversee the planning and execution of outsourced CMC activities and work proactively with service providers to define project scope and ensure successful delivery with regard to technical quality, timelines and budget. S/he will be responsible for identifying/selecting CROs and CDMOs and building/maintaining strong working relationships with their respective technical staff and management.
The Director, Oral Product Development will work within a cross-functional development team environment, supporting TESARO’s senior leadership team in defining and executing against short-, intermediate- and long-term strategic goals for all oral drug product programs. Specifically, the incumbent will be responsible for shaping and defining CMC strategies for oral drug products, including evaluation of available development options/pathways and assessment of attendant benefits and risks. S/he will be expected to represent TESARO at scientific and regulatory meetings and participate in due diligence activities associated with potential in-licensing of new assets.
The individual will report directly to the Executive Director, Drug Product and Analytical Development.
- · Provide technical leadership, management and oversight for:
- o Development and scale up of robust drug product formulations and manufacturing processes based upon quality by design (QBD) concepts that address critical quality attributes and process parameters. Processes must ensure quality, afford satisfactory yields and provide for transferability to commercial manufacturing operations.
- o Manufacturing of non-GLP, GLP and GMP supplies of oral drug products necessary to facilitate TESARO’s non-clinical and clinical deliverables.
- o Registration and validation activities in support of the filing and ultimate launch of TESARO’s portfolio of oral drug products
- o Strategic partners used in the oral drug product development life cycle. Work closely with contract research, development and manufacturing organizations (CRDMO’s) to establish the appropriate operating oversight structure, development and manufacturing goals, program deliverables and budgets and ensures completion of agreed-to development activities.
- · Ensure coordination and oversight of analytical method development, qualification and validation activities associated with oral drug product characterization, lot release and stability testing.
- · Prepare CMC documentation for regulatory and/or patent filings.
- · Establish and maintain an understanding of current trends and emerging oral manufacturing process technologies to ensure that the team is at forefront of oral product development.
- · Apply innovative technical ability and knowledge to critically analyze experimental data and results.
- · Provide clear communication to core teams and functional line management regarding progress against technical objectives/milestones.
- · Ensure well-organized, clear and complete records of all activities across areas of responsibility.
- · Develop and maintain SOPs, policies and guidance documents relevant to areas of responsibility.
- · Manage and execute personnel qualification/training program
- · PhD in pharmaceutics, pharmaceutical Science, pharmacy, chemistry, biotechnology (or related field) or BS/MS with equivalent education or experience is required.
- · Minimum of 10 years of experience in the pharmaceutical industry in small molecule drug product development with a minimum of 5 years in a CMC leadership role.
- · Expert knowledge of oral drug product formulation, manufacturing and process technologies and experience in advancing oral drug products through clinical development to successful regulatory approval/licensing
- · Experience in preparing and defending regulatory documents (NDSs/MAAs).
- · Knowledge of cGMP regulations.
- · Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration a multi-disciplinary business and science team environment is essential.
- · Ability to work in a fast-paced and dynamic corporate environment with changing priorities, and flexibility to support multiple development programs simultaneously.
- Experience building technical teams and managing and developing technical personnel.