SENIOR MANAGER, ORAL PRODUCT DEVELOPMENT
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 our community of dedicated and innovative associates.
Your impact at TESARO:
The Senior Manager, Oral Product Development (PD) will manage the formulation, process development and manufacturing for one or more of TESAROs development programs from Phase 3 registration through commercial process performance qualification (PPQ). The candidate will serve as the subject matter expert (SME) on internal and virtual chemistry, manufacturing and control (CMC) cross-functional project teams. S/he will work with the PD leadership, PD, the CMC team and project management group to optimize product development objectives by providing input on items such as risk profiles, technical challenges and budgetary considerations. S/he will work with internal and external stakeholders to define, manage and interpret results for CMC related activities in support of global clinical development, product registration and process qualification. The ideal candidate will serve as the PD area technical expert on CMC program teams and is responsible for the delivery of PD objectives in alignment with registration and commercial strategies.
* Manage the scale-up, PAR/NOR analysis, technology transfer (if required), and PPQ for an oral drug product program within TESAROs development portfolio.
* Serve independently as drug product development representative on CMC development teams.
* Maintain timely and effective documentation and written accounts of key development deliverables to ensure the knowledge base needed for internal decisions and regulatory filings are captured.
* Manage the manufacturing and on time delivery of clinical supplies in support of TESAROs audacious clinical plans.
* Facilitate a highly cross-functional internal and virtual CMC team environment though engaged management, collaborative interactions and a data driven, quality focused mentality.
* Meet with the PD Leadership, PD and CMC team leads to ensure broad CMC strategies are aligned and review recent results, set next plans, and assure progress is being made on assigned programs.
* As appropriate, support preparation of RFPs and assess technical capabilities for vendor selection, may perform technical audits of CMC vendors. May provide oversight and technical management of certain contracted CMC activities.
* BS (minimum) or MS/PhD (preferred) in a related scientific discipline with 8-10 years (BS) or 5 years (MS/PhD) of biotech/pharmaceutical industry experience in oral product development
* Strong fluency in pharmaceutics with extensive experience with vendor management.
* Demonstrated knowledge, with a successful track record, in managing multiple of the following oral drug product development activities, drug product process scale up, technology transfer and PPQ.
* Knowledge of drug delivery solutions to facilitate the delivery of challenging compounds.
* Ability to provide subject matter leadership in virtual product development and CMC teams.
Knowledge of cross-functional drug development processes, FDA/ICH/EMA guidelines and cGMPs.
Working knowledge of phase appropriate CMC development strategies and regulatory requirements across IND-NDA stages (or their regional equivalents).
Experience in preparation and submission of CMC documents in support of regulatory filings.
Ability to maintain a flexible work schedule to accommodate program priorities and international activities, as needed.
* Travel (international) is required.
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.