Senior Manager, Principal Process Engineer - Lifecyle Management, Cell Therapy (R1555646-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.
- Oversee implementation of LCM projects and transfers between sites for commercial cell therapy products.
- Develop and implement process improvement projects to improve robustness, scalability and COGs for cell therapy products
- Partner with product technical stewards and Regulatory teams to align on LCM strategy and manage implementation
- Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions
- Prepare/Review technical reports and source documentation to support product lifecycle and regulatory submissions.
- Partner with system integration teams, business process owners and other global teams to align process data handling initiatives within the LCM projects
Specific Knowledge, Skills, Abilities, etc:
- The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
- Experience should include strong knowledge and technical leadership and proven track record of managing LCM projects
- Demonstrated leadership skills, and the ability to interact with and lead diverse groups and teams are essential.
- Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team-based environment are required
- Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment required, cell therapy development/manufacturing experience is a plus.
- Strong experience with SOPs, change controls, cGMPs and the know how to work within a regulatory environment required
- Prior experience facilitating/participating in Risk Assessments required
- Prior experience with change controls and quality management systems
- Degree in Biochemical or Chemical Engineering or Sciences: Minimum of a Bachelor’s degree with 10+ years of experience, Master’s degree with 8+ years or Ph.D. degree with 5+ years
- Familiarity with cell therapy processes is preferred.
- Ability to effectively lead cross functional teams, meet deadlines, and prioritize responsibilities.
- Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
- Excellent problem-solving skills, including issue resolution
- Ability to assess risk and develop contingency plans for process risks
- Able to manage time and elevate relevant issues to management and governance forums.
- Detail oriented with excellent verbal and written communication skills.
- Strong interpersonal and leadership skills to work with teams in different functions and organizations
- Position requires repetitive use of hands and wrist (computer work)
- Occasional bending, twisting and stooping to allow for gowning into classified environment required
- Position is primarily office based with occasional work in a classified GMP manufacturing environment
- Position is a team & project-based position that may require occasional shift work, weekends, and holidays
This position may require up to 10% of travel
Supervisory Responsibilities: (only include if supervisory responsibilities are required). This is an individual contributor role
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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