Do you have the passion to join a young global bio-pharmaceutical whose sole mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a rapidly expanding company with multiple marketed products and a diverse and robust pipeline? If yes, you may be a great fit for our community of dedicated and innovative associates.
Your impact at TESARO:
Responsible for building and leading a vertically integrated team of scientists/engineers responsible for the development and manufacture of oral drug products. 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. Responsible for identifying/selecting CROs and CDMOs and building/maintaining strong working relationships with their respective technical staff and management. Work within a cross-functional development team environment and executing against short-, intermediate- and long-term strategic goals for all oral drug product programs. 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.
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 transfer-ability to commercial manufacturing operations.
Manufacturing of non-GLP, GLP and GMP supplies of oral drug products necessary to facilitate TESARO’s non-clinical and clinical deliverables.
Registration and validation activities in support of the filing and ultimate launch of TESARO’s portfolio of oral drug products
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.
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.
Maintenance of technical data and reports; proactive collaboration a multi-disciplinary business and science team environment is essential.
Experience building technical teams and managing and developing technical personnel.
TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Internal Number: 18000045
Do you have the passion to join a young global biopharmaceutical whose sole mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a rapidly expanding company with multiple marketed products and a diverse and robust pipeline? If yes, you may be a great fit for TESARO and our community of dedicated and innovative associates.