Scientist, Manufacturing Technology at Bristol Myers Squibb

Devens, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Oct, 26

Salary

138494.0

Posted On

05 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biologics Manufacturing, Root Cause Analysis, CAPA Development, cGMP Compliance, Process Validation, Technology Transfer, Statistical Data Analysis, Deviation Investigation, Lifecycle Management, Project Management, Upstream Processing, Downstream Processing, CMC Documentation, Risk Assessment, Process Monitoring, Cross-functional Collaboration

Industry

Pharmaceutical Manufacturing

Description

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. Join Bristol Myers Squibb’s Devens Manufacturing Science and Technology- Manufacturing Technology team as a Scientist supporting commercial biologics manufacturing. In this role, you will serve as a process technical expert for large-scale cell culture and single-use manufacturing operations, providing science- and data-driven support to sustain GMP compliance, resolve complex process issues, and ensure reliable supply of life-changing therapies to patients. As a key member of the Manufacturing Technology- Process Technical Operations team, you will serve as a technical lead for commercial biologics manufacturing, leading and supporting deviation investigations, root cause analyses, CAPA development, process monitoring, continuous process verification, change controls, regulatory inspection readiness, and lifecycle management activities. You will apply process knowledge, manufacturing data, and scientific judgment to identify trends, resolve complex process challenges, improve process robustness, and support reliable GMP execution. In this role, you will collaborate closely with Manufacturing, Quality, MS&T, Validation, Analytical, Technical Product Teams, and site leadership to strengthen process performance, enable technology transfer, and advance continuous improvement across biopharmaceutical manufacturing. This opportunity is ideal for a technically strong, collaborative scientist who thrives in a fast-paced, data-driven environment and is motivated by solving complex problems that directly support BMS’s mission to deliver patient-focused therapies. Major Duties and responsibilities: Provide technical expertise and floor support for commercial biologics manufacturing operations, including investigation and resolution of process deviations, troubleshooting of process upsets, assessment of process performance, and identification of opportunities to improve process robustness, reliability, and efficiency. Lead and support root cause investigations for process deviations, including development of scientifically sound impact assessments, risk-based conclusions, and effective CAPAs to prevent recurrence and support timely batch disposition. Serve as a process subject matter expert for internal audits, regulatory inspections, technical discussions, and health authority interactions, including preparation of inspection-ready technical rationale, supporting documentation, and responses. Provide on-call technical support for 24x7 manufacturing support for large-scale cell culture and single-use biologics manufacturing operations, as needed. Demonstrate strong knowledge of cGMP expectations, BMS corporate standards, site procedures, regulatory requirements, and quality systems, and incorporate these expectations into investigations, change controls, technical assessments, and project deliverables. Support process technology transfer, process validation, process performance qualification, post-approval changes, and preparation or review of CMC documentation for regulatory filings and health authority responses. Lead and manage cross-functional technical projects that support process robustness, yield improvement, cost of goods reduction, digital manufacturing, operational excellence, and manufacturing performance objectives. Evaluate process performance using manufacturing data, historical process knowledge, statistical tools, and cross-site or prior campaign comparisons to identify trends, assess process capability, and recommend process enhancements. Author, review, and approve technical documents including protocols, reports, SOPs, technical assessments, risk assessments, impact assessments, campaign summaries, and other GMP documentation supporting commercial biologics manufacturing. Author and Review change controls, technical assessments, and supporting documentation to ensure technical accuracy, process alignment, GMP compliance, and regulatory consistency. Collaborate effectively with Manufacturing, Quality Assurance, Validation, Analytical, MS&T, Technical Product Teams, Supply Chain, Engineering, and site leadership to resolve technical issues, align decisions, and drive timely execution of site priorities. Actively contribute to a culture of safety, quality, accountability, continuous improvement, and scientific excellence by identifying risks, escalating concerns appropriately, and driving practical, compliant solutions. Knowledge & Skills Knowledge of process engineering and science generally attained through studies resulting in a B.S., in engineering (like Biochemistry, Chemical or Biotechnology), a related discipline, or its equivalent. Graduate education through M.S. or Ph.D. is highly desired. A minimum of 6 years relevant experience in biopharmaceutical industry or its equivalent. Strong understanding of commercial biologics drug substance manufacturing, including upstream and/or downstream unit operations, process control strategy, facility operations, and GMP manufacturing execution. Demonstrated knowledge of SOPs, cGMPs, quality systems, regulatory expectations, and the ability to work effectively within a highly regulated manufacturing environment. Strong experience leading or supporting process deviation investigations, root cause analysis, impact assessments, CAPA development, and risk-based technical decision-making. Demonstrated ability to evaluate process data, identify meaningful trends, apply statistical or data analysis tools, and translate data into technically sound recommendations. Experience supporting continuous process verification, annual product quality review, campaign summaries, process monitoring, process validation, and/or process performance qualification activities. Experience with process technology transfer, process validation, lifecycle management, post-approval change support, and regulatory filing or inspection readiness activities. Experience in the design, modification, optimization, and troubleshooting of biologics manufacturing processes, equipment, and/or unit operations. Proven ability to lead and influence cross-functional teams, manage multiple technical priorities, and deliver results within project timelines in a matrixed environment. Demonstrated project management capability, including the ability to define scope, coordinate activities, manage risks, communicate status, and escalate issues appropriately. Broad knowledge of biopharmaceutical facility design, manufacturing operations, GMP documentation practices, and regulatory submission or inspection support. Experience with manufacturing data systems, statistical analysis tools, process historian tools, electronic batch records, DeltaV, or recipe-based manufacturing execution is highly desired. Excellent verbal and written communication skills, including the ability to clearly present complex technical information to manufacturing teams, quality partners, site leadership, and regulatory or audit audiences. Strong interpersonal and facilitation skills with the ability to build alignment, influence across functions, and drive decisions while maintaining a patient-focused, quality-first mindset. 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: Devens - MA - US: $114,290 - $138,494 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. R1603924 : Scientist, Manufacturing Technology Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Responsibilities

Serve as a technical expert for large-scale cell culture and single-use biologics manufacturing to ensure GMP compliance and reliable supply. Lead deviation investigations, root cause analyses, and continuous process verification while collaborating with cross-functional teams to improve process robustness.