Scientist, Manufacturing Technology

About the role

Join Bristol Myers Squibb’s Devens Manufacturing Science and Technology- Manufacturing Technology team as a Scientist supporting commercial biologics manufacturing.

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.

Requirements

A minimum of 6 years relevant experience in biopharmaceutical industry or its equivalent.

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.
• 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.
• Prominent 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.