Senior Scientist, Biostatistics, CPV – MSAT Full-time NEW

Senior Scientist, Biostatistics, CPV – MSAT

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.

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 Senior 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:

• Provides support to maintain the site Statistical Process Control (SPC) program, manufacturing performance trending and reporting.
• Provide multivariate analysis (MVA) modeling for improved process understanding and robustness.
• Continuously monitor CPV parameters, evaluate Statistical Alert Events (SAEs), and take needed actions.
• Collaborate and support investigations by providing data and analysis.
• Meet CPV and APQR timelines.
• Establish and support predictive process monitoring analytics.
• Supporting any proactive initiatives or investigations related to drift in product performance.
• Represent the site MSAT CPV team in cross-functional forums.
• Performing review and approval of site documents within the scope of CPV and APQR.
• Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; actively supporting regulatory inspections.
• Interacting with other teams including Operational Excellence, PMO (Project Management Organization), site MSAT, Global MSAT, Quality Assurance, Process Support/Engineering and Manufacturing support, Manufacturing Operations, Supply Chain Operations.
• Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities.
• Identify key Opex opportunities, using data driven evaluations.

Knowledge & Skills:

• Excellent knowledge of evaluating data using statistics and statistical tools, to make data driven decisions.
• Proficiency in major statistical software packages and programming languages (e.g., Python, R, JMP, MINITAB, or SAS). JMP software preferred.
• Must be detail oriented and proven track record of impeccable time management, to meet timelines.
• Possess strong verbal/written communication skills to enable working with internal/external parties and/or collaborating with cross-functional teams.
• Expert knowledge of cGMP's and multi-national biopharmaceutical/cell therapy regulations.
• Experience of facility/clean room design, process, equipment, automation, and validation.
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities.
• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
• Experience with Operational Excellence and Lean Manufacturing.

Minimum Requirements:

• Bachelor's Degree required (science or engineering is preferred); Graduate or higher-level Degree is preferred.
• 8 or more years of work experience in a manufacturing biopharmaceutical industry.
• Experience in cell therapy manufacturing/support required.
• 4+ years of experience in Continuous Process Verification (CPV) with strong experience performance drive.
• 2+ years of APQR reporting. May be substituted for relevant experience in monitoring/trending performance of Quality attributes.
• 2+ years of automation coding.
• Experience 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:

Summit West – NJ – US: $112,840 – $136,733

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: T he 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