Bristol Myers Squibb Associate Director, Manufacturing Support in Cambridge, Massachusetts
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.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
The Associate Director, Manufacturing Technical Support leads a team of scientists and engineers that support clinical and commercial cell therapy manufacturing. This team is responsible for monitoring, troubleshooting, and improving clinical and commercial cell therapy unit operations. This position reports to the Director of Manufacturing Technology.
DUTIES AND RESPONSIBILITIES:
Builds and leads a team of process subject matter experts that support clinical and commercial cell therapy manufacturing operations.
Provides on call, 24/7 manufacturing support for clinical and commercial pro
Establishes and maintains the site’s process monitoring program. Collaborates with other sites and global teams on the continued process verification program.
Provides process subject matter expertise for process investigations.
Identify, prioritize and drive continuous improvements that reduce safety risks, operational costs, lead times, scrap, and discrepancy rates across all aspects of production. Promote problem identification and the creation of meaningful solutions through a culture of proactive problem prevention
Reviews and approves manufacturing batch records and procedures
Reviews and approves process change controls
Engage and align CMC lifecycle strategy and execution with stakeholders
Provide input to revised and new site-specific as well as global policies and procedures
Influence and review technical content within the CMC sections of regulatory filings
Build and cultivate for the team and site a culture of maintaining a constant state of inspectional readiness
Function as a primary contact for internal and Health Authority audits and driving audit observation corrective actions to closure
Serve as MSAT representative on cross-functional and multi-site teams
Build and maintain effective collaborative relationships across the site and network, influencing site and network product/process life cycle programs
Be an active and visible change agent, promoting flexible and open mindsets to new opportunities. Exercise sound judgment and flexibility while adapting to rapidly changing priorities, challenging situations, and deadlines needed to meet business objectives
Coach and mentor team members thereby enabling their development and career growth
Establish and track performance metrics, provide progress reports to stakeholders
- BS in Engineering or Biotechnology related field. Advanced degree is a plus.
Experience and Qualifications
10+ years relevant experience in cGMP environment for Biologics/CMC/Vaccines
3+ years managing direct reports with varying levels of experience
Subject Matter Expert in cell therapy and/or sterile manufacturing processes, with demonstrated ability to troubleshoot issues and provide technical support.
Experience with Operational Excellence and Lean Manufacturing is highly desired Experience with process technology transfer and validation is a plus.
Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
Experience with internal and health authority audits, particularly pre-licensure inspections (PLIs)
Excellent verbal/written communication skills and ability to influence at all levels
Ability to think strategically and to translate strategy into actions
Ability to prioritize and provide clear direction to team members in a highly dynamic environment
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
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.
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 any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1541549
Updated: 2021-07-31 03:10:03.902 UTC
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.