Principal Scientist API Pharma MS&T (R1558581-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Principal Scientist, API Pharma MS&T
- 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 CMC development teams 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.
- Complete knowledge of process, engineering, analytical and regulatory requirements (cGMP, filing, EHS).
- Demonstrated experience in building relationships and using influence. Great communication and negotiation skills are required for this position as well as the ability to translate technical issues into growth and relevant solutions.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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