Sr Principal Engineer, Cell Therapy Technical Operations
Sr Principal Engineer, Cell Therapy Technical Operations
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$ 143000 - 179000
1 Vacancy
Job Description
Working with Us
Challenging. Meaningful. Lifechanging. 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 highachieving 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: Cell Therapy platform is built on Chimeric Antigen Receptor (CAR) technology enabling the reengagement of the immune system to treat cancer.
Join the Cell Therapy Development and Operations (CTDO) division where we are building leading cell therapy platforms to serve patients with novel immunotherapies. The Cell Therapy Technical Operations (CTTO) group within CTDO plays a critical role in:
- Technology transfer and process validation
- CMC lifecycle management
- Oversight of external manufacturing partners
- Process engineering and standardization to support global manufacturing scaleup and robustness
We are seeking a Senior Principal Process Engineer to join our CTTO team.
Position Summary
The Senior Principal Process Engineer will lead the transfer and lifecycle management of manufacturing processes from development through commercialization. This includes facility fit assessments development of GMP documentation (e.g. batch records forms) training quality systems engagement (e.g. change controls) and crossfunctional collaboration.
The successful candidate will support latephase clinical and commercial programs including PPQ strategy development regulatory filings and technical oversight. This individual will serve as a key technical leader across the product lifecycle driving innovation alignment and harmonization across internal and external manufacturing networks.
Primary Responsibilities
- Lead crossfunctional technology transfers for both cell therapy and vector manufacturing processes
- Oversee development and implementation of process control strategies including risk assessments range justifications and CPV strategies
- Author and contribute to regulatory filings (e.g. IND BLA variations) across product lifecycle stages
- Monitor and evaluate process performance to ensure capability and robustness; support technical investigations as needed
- Develop and manage tools/templates for criticality assessments of process parameters and quality attributes
- Provide technical input into facility and equipment design for clinical and commercial use
- Drive alignment and harmonization of manufacturing processes across internal and external sites
- Foster strong partnerships with Contract Manufacturing Organizations (CMOs) and other external stakeholders
- Provide technical mentorship to junior engineers on complex issues
Required Qualifications
- B.S. M.S. or Ph.D. in Chemical Engineering Biochemical Engineering or a related discipline with:
- 7 years of relevant experience in biologics or cell therapy process development tech transfer or GMP manufacturing support
- Proven ability to operate in crossfunctional teams and manage multiple priorities in a fastpaced environment
- Handson experience in GMP manufacturing environments and deep understanding of process development and validation
- Familiarity with ICH guidelines control strategy development and quality systems (change control deviations CAPAs)
- Strong problemsolving skills with proficiency in data analysis tools (e.g. JMP R Minitab)
- Effective written and verbal communication skills including technical documentation and scientific writing
- Detailoriented organized and selfmotivated
Preferred Qualifications
- Experience authoring regulatory submissions (e.g. INDs BLAs)
- Understanding of cellular immunology or immunotherapy platforms
- Experience with singleuse technologies (SUBs SUMs) cell culture and downstream processing
- Prior experience managing external manufacturing relationships or working with CMOs
The starting compensation for this job is a range from $143000 $179000
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.
Benefitofferingsare subject to the terms and conditions of the applicable plans then in effectand may include the following: Medical pharmacy dental and vision care. Wellbeing supportsuch asthe BMS Living Life Better program and employee assistance programs (EAP). Financial wellbeing resources and a 401(K). Financial protection benefits such as short and longterm disability life insurance supplemental health insurance business travel protection and survivor 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 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
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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 Lifechanging 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.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100% of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Staff IC
Employment Type
Full-Time
