Assist in monitoring patient responses and gathering data for clinical research, ensuring protocol compliance, coordinating sample collection for studies, and maintaining accurate research databases to support research initiatives and patient care.

Title: Senior Scientist, Biostatistics, CPV - MSAT Location: Summit West United States Job Description: time type Full time job requisition id R1601715 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 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. BMSCART, #LI-Hybrid 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: 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. R1601715 : Senior Scientist, Biostatistics, CPV – MSAT

Role Description We are seeking a highly motivated Senior Scientist to lead the outsourcing and lifecycle management of critical reagents supporting programs from Research through Clinical development. This role will provide technical leadership and hands-on oversight for the generation, characterization, qualification, and supply of critical reagents used in nonclinical and clinical studies. The ideal candidate has direct experience developing critical reagents (labeled reference materials, polyclonal antibodies, anti-idiotype antibodies, peptide pools, etc.) and working with external partners to ensure quality, compliance, and continuity of supply. This individual will work cross-functionally to ensure reagent readiness aligned with developmental program timelines. Your Contributions - Lead external development and qualification of critical reagents to support bioanalytical assays from non-GLP through clinical. - Provide scientific oversight for reagent generation, characterization, comparability, and stability. - Ensure appropriate documentation and traceability to support regulatory expectations. - Identify and evaluate external vendors for reagent generation and long-term supply. - Manage day-to-day CRO/CDMO interactions, including timelines, deliverables, and issue resolution. - Monitor vendor performance and proactively mitigate risks to supply or quality. - Develop lifecycle plans for critical reagents from early research through clinical phases. - Support change management activities, including reagent bridging and comparability assessments. - Ensure reagents meet appropriate GxP requirements based on development stage. - Work with Preclinical Operations to establish contracts and work orders for critical reagent generation. - Establish and manage active inventory to ensure consistent material traceability and availability for use across cross-functional teams and external partners. - Lead reoccurring cross-functional discussions around strategy and ongoing campaign updates. Cross-Functional Collaboration - Partner with Bioanalytical, CMC, Nonclinical, Clinical, Regulatory, Research, Legal, and Quality teams to align reagent strategies with program needs. Qualifications - MS in Biology, Biochemistry, Immunology, Pharmaceutical Sciences, or related discipline with 3+ years of industry experience; or BS with 5+ years. - Direct experience generating and/or developing critical reagents (e.g., monoclonal antibodies, PK/ADA/NAb assay reagents, biomarkers, reference standards). - Experience working with external CROs/CDMOs. - Strong understanding of bioanalytical assay development and reagent qualification. - Strong understanding of GLP/GCLP/GMP requirements as applicable to reagent use. - Working knowledge of regulatory expectations for critical reagents supporting INDs and clinical programs. Requirements - The pay you should reasonably expect to receive is $53.26 - $77.21 per hour. - Decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. Company Description

Role Description Lonza is currently seeking an experienced MSAT Scientist II to join their team in Portsmouth, NH. DUTIES: - Work on process transfer and process support to provide all functions associated with process transfer and process support including: - Perform gap analysis - FMEA - Generate process models - Author process descriptions and batch records - Author change controls - Perform process monitoring including manufacturing data summary and analysis - Data presentation - Author campaign summary reports - Perform activities for lot release and assess deviations - Provide guidance on process transfer and support activities to junior members of the team. - Work on deviations, problem solving, and data analysis to assess all major deviations including those that impact product quality. - Identify potential root causes using a systematic approach and potential solutions. - Use a variety of problem-solving tools including Fishbone and Kepner-Tregoe. - Assess change controls for impact of any change to the process, equipment, or procedures that can affect process performance and product quality. - Support documentation preparation for regulatory purposes. - Participate in Customer and Regulatory Audits. - Represent MSAT on project teams and interface with customer technical and quality representatives. - Ensure employee training profile is up to date at all times by regular monitoring of training lists including Compliance Wire, SAP Learning Portal, and completing all training in a timely fashion. - Follow all training and policy guidelines established for the facility as well as all cGMP requirements. - Work on computer skills allowing interface with critical software. - Perform all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis. - Act as a support role for a more senior scientist. - Participate in collecting data for analysis but not expected to perform analysis or interpret data. - Manage MSAT tasks in program schedule and drive tasks to completion. - Develop training activities for the MFG area or MSAT department. - Author process change controls in Trackwise and set due dates appropriately based on scope of work. - Own change control tasks and drive document updates authored by others. - Identify, evaluate, and initiate cost saving projects for a specific customer program. - Develop process understanding. - Act as a reviewer on existing process documents ensuring changes proposed by more senior scientists are being implemented. - Observe troubleshooting activities for learning opportunities. - Work on various software systems including Teams, Word, Excel, Outlook, PowerPoint, Planview, DMS document management system, Statistica, Trackwise, Simca, Global Data Mart, Pi DataLink software, Pi Vision software, Syncade, SAP, Delta V, Power BI, Orchestrate scheduling systems, and various cloud-based data storage systems including SharePoint. - Work on aseptic technique and mammalian cell culture. - Demonstrate knowledge of cell culture bioreactors with sufficient acumen to perform troubleshooting on active cultures during processing. - Understand and interpret statistical models including multivariate analysis presented through Excel, Statistica, Power BI, and similar software. - Demonstrate proficiency with Statistica, Power BI, Simca, and Pi Vision to remotely monitor processing and prepare technical presentations for customers. - Perform product impact assessments of highly technical deviations that occur during GMP production through technical writeups in the TrackWise documentation system. Qualifications - Master’s degree, or foreign equivalent degree in Chemical and Biochemical Engineering or Biotechnology - 2 years of experience in the job offered or in a related occupation - Experience with various software systems including Teams, Word, Excel, Outlook, PowerPoint, Planview, DMS document management system, Statistica, Trackwise, Simca, Global Data Mart, Pi DataLink software, Pi Vision software, Syncade, SAP, Delta V, Power BI, Orchestrate scheduling systems, and various cloud-based data storage systems including SharePoint - Experience working on aseptic technique and mammalian cell culture - Demonstrated knowledge of cell culture bioreactors - Understanding and interpreting of statistical models including multivariate analysis - Proficiency with Statistica, Power BI, Simca, and Pi Vision Requirements - Master’s degree, or foreign equivalent degree in Chemical and Biochemical Engineering or Biotechnology - 2 years of experience in the job offered or in a related occupation Benefits - Opportunity to improve lives around the world - Engagement in solving complex problems and developing new ideas in life sciences Company Description Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.