Process Engineer I-II, Single Use Systems -Cell Therapy

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.

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 Process Engineer I/II to join the Single Use Systems (SUS)/Raw Material (RM) Team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The successful candidate will collaborate with the GMSAT teams in Seattle and New Jersey locations in the US and support efforts related to SUS and RM. The Process Engineer I/II will be responsible for working with cross-departmental teams, planning/executing risk assessments, building strategy for comparability exercises to enable change implementation, and deviation management.

This role is responsible for creating supporting/leading vendor change notifications, supporting dual sourcing strategies, proactive process monitoring using statistics, master plans, and leading investigations. This role will also be responsible for supporting and developing designs and implementation of SUS and RM best practices and new designs.

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

• Collaborate with process engineers and analytical scientists by applying SUS and RM knowledge to support CAR-T and viral vector manufacturing process teams.
• Execution of process risk assessments, development of criteria justifications, and development of RM master plans.
• Support regulatory filings summarizing the strategy and results from comparability exercises.
• Develop, understand, and manage tools and templates that can be used to quantify potential impact of changes on process performance and product quality.
• Lead efforts focusing on alignment and harmonization of comparability strategies across multiple sites.
• Leverage and maintain strong relationships across multiple sites and vendors.
• Coach/support junior staff on the team on complex technical issues.
• Up to 25% travel may be required domestically (primary) and internationally (potentially).

Skills/Knowledge Required:

• B.S. with 3-5 years or M.S. with 2-3 years relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent with 2 years of relevant experience in managing SUS projects.
• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast paced matrix environment.
• Experience or familiar with development and/or characterization of vaccines, biologics and/or cell therapy manufacturing processes.
• Experience working in a GMP environment. Understanding of compendial requirements and how to assess specifications. Familiar with ICH guidelines and control strategy development.
• Experience working with vendors and contract manufacturing sites is preferred
• Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs. Ability to assess risk and develop contingency plans for mitigation.
• Detail oriented with excellent verbal and written communication skills. Strong scientific and technical writing skills. Able to manage time and elevate relevant issues to project lead and line management.
• Proficiency utilizing MS Office products and statistical software (R, JMP, Minitab)

Additional Skills:

• Single Use (SU) component experience is strongly preferred.
• Flexibility to work within manufacturing schedules.
• Familiarity with literature on cell therapy. Experience with cellular therapies is preferred.

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.