ScientistEngineer, Manufacturing Technology

At Bristol Myers Squibb our employees often ask Who are you working fora 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.

Join Bristol Myers Squibbs Devens Manufacturing Science and Technology-Manufacturing Technology team as a Scientist supporting commercial biologics 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 leadfor 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 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 BMSs 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 with 5-7 years relevant experience in biopharmaceutical industry or its equivalent. Graduate education through M.S. (2-4 years of experience) or Ph.D. is highly desired (1-2 years of experience).

• 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.

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

The 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 Years Day.

U.S.-based job seekers can explore full benefit offerings at 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 People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

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BMS will consider qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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