Bristol Myers Squibb MS&T Manager in New Brunswick, New Jersey
MS&T manager based in US (New Brunswick). Will be reporting into Associate Director for development to launch based in ExM Dublin
Working with all relevant departments on new product introduction activities. Partner closely with the product development group (PD) trough clinical manufacture and validation to transfer manufacturing processes to our external commercial sites (CMOs).
Partner with PD to ensure new products under development are designed to support commercial manufacture.
Designee for Pharma MS&T on Integrated development teams (IDT) and Material Science development teams (MSDTs).
Assessing manufacturing requirements and capabilities prior to the transfer of a new process into manufacturing facilities and providing floor support during the validation campaigns, as well as review of process data to ensure operational consistency.
Supporting CMO/vendor selection – preparation of technical information packages, leading technical due diligence and site assessments, technical evaluation of RFIs and RFPs, where required.
Preparation, distribution and presentation of project status reports to project team members and management. Review and approval of technology documents such as Technology Transfer plans, Validation Master plans, process risk assessments etc., where required
Providing manufacturing descriptions and technical evaluations/review for regulatory filings.
Providing technical leadership in the understanding of root causes for out of trend or out of specification results or deviations for API or intermediate manufacturing processes.
Provide technical leadership for change management, investigation CAPA identification and related activities at CMO site.
Qualifications and Experience required:
PhD in scientific or engineering discipline, with at least 7 years or Masters with at least 10 years of experience in product development and relevant industrial experience in the pharmaceutical industry. Experience in leading new product introduction is desirable
Recognised technical leader and subject matter expert in API process development and scale-up, technology transfer, process management, trouble-shooting and optimisation, and relevant synthesis and degradation chemistry.
Demonstrated project management and technical leadership capability. Ability to build effective teams made up of diverse contributors.
Solid experience in commercial manufacturing of API in accordance with GMP standards in an external manufacturing environment.
Thorough knowledge and understanding of process, engineering, analytical and regulatory requirements (cGMP, filing, EHS).
Demonstrated experience in building relationships and using influence. Excellent communication and negotiation skills are required for this position as well as the ability to translate technical issues into business impact and relevant solutions.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.