Manager, Senior Engineer I - Material Science & SUS

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us

Job Purpose / Position Summary

BMS is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. We are developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

We are looking for a Senior Engineer 1 to join the raw materials team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviation management, process improvements to support CAR-T therapies during late stage clinical, tech transfer, and commercial production.

Responsibilities include, but are not limited to, the following:

• Serve as a SME for single-use systems (SUS) and material sciences.
• Provide technical support on in CAR-T commercial manufacturing.
• Lead projects involving the introduction and qualification of materials, second sourcing efforts, and development of material specifications.
• Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and supply chain robustness of existing raw materials.
• Deliver strategies for prioritizing and executing raw material projects, including the establishment and improvement of internal standards and business processes.
• Vendor management including change controls, audits, deviations, and QRM programs.
• Support investigations and ensure compliance with internal standards and requirements.
• Perform technical diligence visits to raw material supplier sites with cross-functional teams.
• Provide necessary technical analysis to support impact assessments and investigations.
• Author responses for Information Request (IR) from regulatory bodies.
• Provide mentorship or management of junior member(s) of the team.

Skills/Knowledge Required:

• B.S. with 6-8 years of experience or M.S. with 5+ years relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent.
• Subject matter expert of raw materials (both liquid and single use system).
• Understanding of regulatory/compendial requirements for raw materials used in biomanufacturing.
• Experience working with vendors and contract manufacturing sites.
• Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
• Ability to assess risk and develop contingency plans for process risks.
• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Detail oriented with excellent verbal and written communication skills.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations.
• Experience with Quality Management System (Ex. Deviation, CAPA, Change Management).
• Knowledge of GMP manufacturing practices and documentation requirements.

Additional Skills:

• Technical experience working with raw material suppliers for biopharmaceutical or cell therapy manufacturing, including collaborative engagement on investigations, technical diligence, and strategic initiatives.
• Experience writing and/or supporting protocols and testing for Extractables and Leachable (E&L) studies.
• Previous experience with raw material supplier selection, supplier relationship management and performing technical diligence visits and/or quality audits.
• Understanding of key considerations for single-use containers used for raw materials.
• Familiarity with raw material supply chains and manufacturing methods.
• Experience with commercial product support, i.e., post-marketing commitments.
• Contributions to industry consortia (e.g., BPOG) to drive establishment and improvement of industry best practices and standards for raw material development and management.
• Lean Manufacturing experience is desired.

The starting compensation for this job is a range from $92,000 - $115,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.

BMCART

#Li-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
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.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.