Cpv Jobs (NOW HIRING)

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. 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.

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 t...