Sr. Principal/Associate Director, Process Engineer

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. 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 .

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMSs continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

We are looking for a Process Engineer to join the drug product team within the Cell Therapy Technical Operations (CTTO) team. CTTO is responsible for support and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product life-cycle from pre-clinical through commercial manufacturing. The Sr. Principal Engineer will be responsible for the implementation of cell therapy manufacturing technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (global guidance documents, process control strategies, process risk assessments, etc), inspection readiness, and technical regulatory submissions. The Sr. Principal Engineer will support commercial product lifecycle management, including authoring of technical assessments and monitoring process performance including, but not limited to, continued process verification. The role collaborates across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

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

• Lead process and technology transfers, change management, and technical process support for commercial cell therapy products.
• Owner of process control strategies including process risk assessments and continued process verification.
• Comprehensive data analyses using historical process experience and characterization studies to identify trends in process performance and drive changes in the process control strategy and risk assessments
• Lead production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Own Stage III validation (CPV) reports including process monitoring of manufacturing processes to understand process capability and performance drift over time.
• Provide necessary technical analysis to support impact assessments and investigations.
• Develop, execute and implement manufacturing process improvement activities in accordance with the overall life cycle plan for the product
• Share operational and process leanings with the rest of the manufacturing network

Basic Qualifications:

• MSc, or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 12+ years of relevant experience. Familiarity with cell therapy processes and cGMPs is preferred.
• Ability to effectively lead cross functional teams, meet deadlines, and prioritize responsibilities.
• Advanced data management and statistical analysis skillset
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
• Ability to assess risk and develop contingency plans for process risks
• Able to manage time and elevate relevant issues to project lead and line management.
• Detail oriented with excellent verbal and written communication skills.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations

Preferred Qualifications:

• Experience with cell therapy process development and / or manufacturing
• Experience with technology transfer in a manufacturing environment
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Spotfire, Minitab)
• 10-12 years of experience in cell therapy process development, MS&T, and/or manufacturing
• Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability

The starting compensation for this job is a range from $156,000 - $195,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the geographic location where work is performed. Final, individual compensation is decided commensurate with demonstrated experience. For more on benefits, please visit our BMS Careers Site. Eligibility for specific benefits listed therein may vary based on job and location.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Years holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

If you come across a role that intrigues you but doesnt 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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments 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 cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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