Senior Scientist, Biostatistics, CPV – MSAT

Bristol Myers Squibb • Summit, NJ

20h • Hybrid

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• Experience with Operational Excellence and Lean Manufacturing is a plus.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees