Scientist Biostatistics, CPV-MSAT
Bristol Myers Squibb
This listing was originally posted on Bristol Myers Squibb's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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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. 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.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.
The Scientist of Biostatistics is a member of the MSAT team, with focus in CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting. The incumbent will support the monitoring/trending of production and release testing parameters, in support of product of personalized cell therapy products for both global commercial and clinical trial supply. The Incumbent will trend CPV parameters, including but not limited to Manufacturing process parameters and Quality Control Release attributes for the MSAT organization, to support the Summit, NJ Cell Therapy facility.
The purpose of a CPV program is to provide evidence that a process is running under a state of control. The incumbent will monitor/trend, alerting stakeholders of any drifts and supporting the data reporting of process parameters to the global MSAT organization, while meeting established timelines. The CPV program includes supporting the APQR, as required by regulatory agencies. The incumbent will support the CPV and APQR reports and approvals. The organization being supported is a 24x7x365 manufacturing facility. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ Building S12. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.
Shift Available:
Monday - Friday, Hybrid Day Shift, 8 a.m. - 4:30 p.m.
Responsibilities:
Assist in maintaining the site Statistical Process Control (SPC) program, supporting manufacturing performance trending and reporting under the direction of senior team members
Support multivariate analysis (MVA) modeling activities to contribute to process understanding and robustness
Collaborate with cross-functional teams and support investigations by providing relevant data and analysis
Assist in meeting CPV and APQR timelines by completing assigned tasks accurately and on schedule
Support the development and maintenance of process monitoring analytics under senior guidance
Contribute to proactive initiatives or investigations related to drift in product performance
Participate in cross-functional forums as a representative of the MSAT CPV team, as needed
Assist in the preparation and review of site documents within the scope of CPV and APQR
Support safe and compliant cGMP operations and contribute to maintaining inspection readiness
Interact with teams including Operational Excellence, PMO, site MSAT, Quality Assurance, Process Support/Engineering, Manufacturing Operations, and Supply Chain Operations
Stay current with industry trends and BMS standards by participating in relevant training and best practice forums
Support identification of Operational Excellence (Opex) opportunities through data-driven evaluations
Knowledge & Skills:
Working knowledge of statistical methods and tools used for data-driven decision-making in a manufacturing environment
Proficiency in at least one major statistical software package and programming languages (e.g., R, JMP, MINITAB, or SAS). JMP software preferred.
Detail oriented with strong time management skills to meet project timelines
Good verbal and written communication skills, with the ability to work effectively in a cross-functional team environment
Working knowledge of cGMP requirements and biopharmaceutical/cell therapy regulations
Basic familiarity with facility/clean room operations, process equipment, and manufacturing workflows
Exposure to single-use technologies, closed systems, or cold chain/cryogenic technologies is a plus
Familiarity with Operational Excellence and Lean Manufacturing principles is a plus
Minimum Requirements:
Bachelor’s Degree required (science or engineering is preferred); Graduate or higher-level Degree is preferred
5 or more years of work experience in the biopharmaceutical or related industry
5 or more years of manufacturing support or related experience in the biopharmaceutical industry
Exposure to or basic experience with CPV and/or APQR reporting is preferred; relevant experience in monitoring/trending Quality attributes may be substituted
Experience in cell therapy, biologics, or vaccine manufacturing/support preferred
Familiarity with Operational Excellence and Lean Manufacturing is a plus
Working conditions:
The incumbent will be required to adhere to the current BMS policies and procedures.
The incumbent will be required to gown to access classified manufacturing areas when needed.
BMSCART, #LI-Hybrid
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.
The Scientist of Biostatistics is a member of the MSAT team, with focus in CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting. The incumbent will support the monitoring/trending of production and release testing parameters, in support of product of personalized cell therapy products for both global commercial and clinical trial supply. The Incumbent will trend CPV parameters, including but not limited to Manufacturing process parameters and Quality Control Release attributes for the MSAT organization, to support the Summit, NJ Cell Therapy facility.
The purpose of a CPV program is to provide evidence that a process is running under a state of control. The incumbent will monitor/trend, alerting stakeholders of any drifts and supporting the data reporting of process parameters to the global MSAT organization, while meeting established timelines. The CPV program includes supporting the APQR, as required by regulatory agencies. The incumbent will support the CPV and APQR reports and approvals. The organization being supported is a 24x7x365 manufacturing facility. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ Building S12. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.
Shift Available:
Monday - Friday, Hybrid Day Shift, 8 a.m. - 4:30 p.m.
Responsibilities:
Assist in maintaining the site Statistical Process Control (SPC) program, supporting manufacturing performance trending and reporting under the direction of senior team members
Support multivariate analysis (MVA) modeling activities to contribute to process understanding and robustness
Collaborate with cross-functional teams and support investigations by providing relevant data and analysis
Assist in meeting CPV and APQR timelines by completing assigned tasks accurately and on schedule
Support the development and maintenance of process monitoring analytics under senior guidance
Contribute to proactive initiatives or investigations related to drift in product performance
Participate in cross-functional forums as a representative of the MSAT CPV team, as needed
Assist in the preparation and review of site documents within the scope of CPV and APQR
Support safe and compliant cGMP operations and contribute to maintaining inspection readiness
Interact with teams including Operational Excellence, PMO, site MSAT, Quality Assurance, Process Support/Engineering, Manufacturing Operations, and Supply Chain Operations
Stay current with industry trends and BMS standards by participating in relevant training and best practice forums
Support identification of Operational Excellence (Opex) opportunities through data-driven evaluations
Knowledge & Skills:
Working knowledge of statistical methods and tools used for data-driven decision-making in a manufacturing environment
Proficiency in at least one major statistical software package and programming languages (e.g., R, JMP, MINITAB, or SAS). JMP software preferred.
Detail oriented with strong time management skills to meet project timelines
Good verbal and written communication skills, with the ability to work effectively in a cross-functional team environment
Working knowledge of cGMP requirements and biopharmaceutical/cell therapy regulations
Basic familiarity with facility/clean room operations, process equipment, and manufacturing workflows
Exposure to single-use technologies, closed systems, or cold chain/cryogenic technologies is a plus
Familiarity with Operational Excellence and Lean Manufacturing principles is a plus
Minimum Requirements:
Bachelor’s Degree required (science or engineering is preferred); Graduate or higher-level Degree is preferred
4 or more years of work experience in the biopharmaceutical or related industry supporting manufacturing.
At least one year with direct exposure with CPV and/or APQR reporting; relevant experience in monitoring/trending Quality attributes may be substituted.
At least one year experience in cell therapy, biologics, or vaccine manufacturing/support.
Familiarity with Operational Excellence and Lean Manufacturing is a plus.
Working conditions:
The incumbent will be required to adhere to the current BMS policies and procedures.
The incumbent will be required to gown to access classified manufacturing areas when needed.
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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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.
Supporting People with Disabilities
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.
Candidate Rights
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: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
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