Senior Scientist/Engineer, Manufacturing Technology
$120.74k - $146.31kBristol Myers Squibb
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position: Senior Scientist/Engineer, Manufacturing Technology (Process Transfer, Validation and Projects)
Location : Devens, MA
Position Summary
The Senior Scientist/Engineer is a subject matter expert and process/project owner for biologic drug substance commercial technical transfers, process validations and project portfolio at Bristol Myers Squibb, Devens. The position will be responsible for supporting the authoring and execution of process validation protocols, reports and exceptions (as applicable), and for key sections of Chemistry, Manufacturing, and Controls (CMC) submissions, along with setting relevant standards and procedures.
This position will report to the Associate Director, Process Transfer and Validation. The successful candidate will leverage technical ability, stakeholder management and excellent communication ability to deliver Devens site, MS&T and business unit priorities. They will work with site support organizations (Manufacturing, Supply Chain, Digital Plant, Site Engineering, and Quality Assurance) to remove obstacles and ensure timely results.
Key Responsibilities
Responsible for supporting the execution of biologics drug substance projects including commercial technology transfer, technical oversight of process design, process validation/re-validation, regulatory package authoring and successful inspection and approval for the Devens Biologics site.
- Influences technical direction for biologics drug substance manufacturing across media/buffer, cell banking, cell culture, purification, formulation and fill through to freeze.
- Working knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, and process control fundamentals in technical transfer and post approval process changes.
- Support the delivery of complex technical projects within biologics drug substance manufacturing and drives decisions that require developing new options to solve highly complex and/or novel problems.
- Responsible for supporting technical aspects of site regulatory inspections with thorough understanding of regulatory environment and industry trends for biologics drug substance specifically in relation to Pre-Approval Inspections (PAI) supporting technical transfer and post approval process changes.
- Is responsible for the timely delivery of assigned projects across technical transfer, process validation/qualification, and post approval process changes at Devens Biologics.
- Routinely interacts within the MS&T internal BMS network for technical and operational improvements and issue resolution.
- Drives effective working relationships with other functional organizations, such as Quality, Operations, Engineering, Global Regulatory Science, Technical Product Teams and others, both internally and externally to the site.
Qualifications & Experience
Bachelor’s degree in a relevant engineering or scientific discipline and 7–9 years of relevant experience, or a Master’s degree and 4–6 years of relevant experience, or a PhD and 2–4 years of relevant experience. A combination of education and experience may be considered where appropriate.
- Technical execution experience in a commercial technical support function is preferred (MS&T, MT, Manufacturing Engineering, or similar). Experience with technology transfer, Process Performance Qualification is a plus. The successful candidate should possess a working knowledge of global regulatory requirements related to the design and control of biologics drug substance processes.
- Working knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, and process control fundamentals in commercial manufacturing.
- Excellent communication and presentation skills and vast experience interfacing with multiple stakeholders and partner functions
- Ability to work in a fast paced, complex and changing environment.
- Excellent analytical, technical, and strategic thinking skills and experiences.
- Strong understanding of project management systems and tools is preferred.
- Excellent organizational skills and the ability to successfully manage a multitude of technical projects.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
Devens - MA - US: $120,740 - $146,312The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at
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 View email address on aiapply.co . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: 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:
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 .
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at View email address on aiapply.co with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
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