Position Summary

Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products. The Senior Manager, API Development manages the operational activities of assigned drug substance development projects using an outsourcing model.  Focus includes API process development, analytical development and campaign manufacture.  The individual will participate in the creation of CMC development strategies, integrating API development requirements with the cross-functional CMC plan, and in alignment with the Core Program Team objectives.  This will include oversight of the execution of outsourced activities and proactively working to manage vendors with regard to scope, timelines, and milestones.  Work may further include the drafting and review of technical and GMP documents, scientific manuscripts, as well as supporting the preparation of CMC documents for regulatory filings and patent applications.

The Senior Manager will have the responsibility to work within CMC development teams for assigned programs.  Effective communication of proposed API development study designs, available scientific data, and vendor development options, along with associated timelines and costs, are core components of the role.  Key success factors include an ability to work in a virtual model with effective management of third party vendors to mutual benefit.

The individual will report directly to the Sr. Director, API Pharmaceutical Development.

Responsibilities

• Manages API operational activities predominantly associated with small molecules at early to mid-stage development under an outsourcing model
• Oversees the daily development and production activities at CMO’s to ensure they generate quality scientific data and meet the agreed development and delivery timelines
• Works with the Sr. Dir., API Pharmaceutical Development and vendors for the creation of technical and GMP documents.  Assists in the review of technical documents including summary reports, batch records, analytical methods and specifications
• Works with the Sr. Dir., API Pharmaceutical Development to support analytical method development, qualification and validation for the purpose of drug substance characterization, lot release and stability testing
• Contributes, as a CMC representative, to the program team’s overall objectives
• Helps prepare CMC documents suitable for regulatory and/or patent filings
• Helps identify suitable vendors with needed API development competencies; provides input for proposal generation and manages the RFP process
• Manages technology transfer and documentation of API development history for assigned projects
• Helps research new chemistry and technologies which could potentially improve the API process and reduce the COGs
• Manages API inventory including the generation of demand/supply tracking tables, projection of delivery timelines, batch re-certification and execution of API shipment

Education/Experience Requirements

• PhD or equivalent in synthetic organic or organometallic chemistry
• 6-8 years of industry related experience in chemical process research and development
• First-hand experience in developing and scaling up efficient synthetic routes in lab, kilo-lab, and pilot plant
• Working knowledge of analytical principles, data interpretation, and equipment including but not limited to GC, HPLC, NMR, DSC, TGA, and XRPD
• Working knowledge of chemical engineering and plant settings and operations
• Proven experience in the management of projects at early to mid-stage development
• Successful track record for the technology transfer of API processes to CRO’s and CMO’s, including the effective completion of agreed upon development objectives with high quality and to expected timelines and budgets
• Effective leadership of cross-functional collaboration of both internal and external teams
• Demonstrated knowledge of SOPs, GLP, cGMP, and FDA and ICH regulatory guidelines
• Strong regulatory writing skills and familiarity with the preparation of regulatory documents (IND’s, NDA’s)
• Excellent written and oral communication skills, including the maintenance of technical data and reports
• Willingness to work in a dynamic and changing corporate environment.
• Ability to work independently and with flexibility to handle work flow in a multi-tasking environment.
• Requires a flexible work schedule to accommodate program priorities as needed.
• Some international travel may be required.