Associate Director, Aseptic Process and Design

Bristol Myers Squibb

. Design and develop aseptic manufacturing processes, including fill/finish operations and sterile processing systems .

Posted 9/17/2026full-timeNew Brunswick • New Jersey • United StatesSenior💰 $161,950 - $209,976 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in aseptic manufacturing processes, including cleanroom design, contamination control, and process validation. Proficient in regulatory compliance with cGMP, FDA, and ISO standards, while leading cross-functional teams to optimize manufacturing operations.

Highest-signal resume keywords

Aseptic ProcessingProcess ValidationCleanroom DesignRegulatory ComplianceProject Management

ATS Keywords

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Hard Skills

Aseptic ManufacturingSterile Processing SystemsMicrobial Critical Process ParametersProcess OptimizationEquipment CommissioningSterilization TechnologiesData AnalysisRoot Cause AnalysisRisk AssessmentsContinuous Improvement

Soft Skills

Effective CommunicationCross-Functional CollaborationLeadershipAttention to DetailOrganizational Skills

Tools & Technologies

Filling LinesIsolatorsRABSSterilization SystemsEnvironmental Monitoring Systems

Certifications & Qualifications

B.S. in MicrobiologyPharmaceutical SciencesBiologyBiochemistryChemical EngineeringBiotechnology

Industry Keywords

CGMPFDAEU GMP Annex 1ISO 13408ICH Q8/Q9/Q10Media Fill StrategyContamination ControlSterile FiltrationTechnical DocumentationInspection Readiness

About the role

Key responsibilities & impact

Design and develop aseptic manufacturing processes, including fill/finish operations and sterile processing systems
Define cleanroom layouts, material/personnel flows, and environmental control strategies to minimize contamination risks
Support sites in evaluating and selecting aseptic manufacturing equipment and technologies, including filling lines, isolators, RABS, and sterilization systems
Establish microbial critical process parameters and develop robust aseptic manufacturing formulas
Lead process optimization to improve yield, reliability, and sterility assurance
Support scale-up and technology transfer from development to commercial manufacturing
Support or lead commissioning and qualification (IQ/OQ/PQ) of aseptic systems and production lines
Develop and execute process validation strategies, including media fills and continued process verification
Ensure processes remain in control through lifecycle monitoring and continuous improvement
Define enterprise APS/media fill strategy, including governance, intervention classification, acceptance criteria, and continuous improvement expectations
Provide expert oversight and standardization of smoke study program design and execution
Establish and maintain enterprise policies governing media fill frequency, unit operation coverage, failure investigations, and remediation pathways
Facilitate cross-site learning and consistency in APS program design across the BMS network
Support sites in integrating Contamination Control & Sterility requirements into process design and operational practices
Assess microbial contamination risks and define mitigation strategies
Integrate environmental monitoring, cleaning validation, and sterilization practices into process design
Ensure compliance with cGMP, FDA, EU GMP Annex 1, ISO standards, and ICH guidelines
Support regulatory submissions, inspections, and audits with technical documentation
Develop SOPs and technical documentation and provide input on aseptic-process batch records
Assist sites with inspection-readiness materials and serve as a technical SME during regulatory inspections
Partner with Quality, Manufacturing, Engineering, MS&T, and Validation teams
Provide SME support for troubleshooting and deviation investigations
Lead or contribute to capital projects, technology transfers, and process improvements

Requirements

What you’ll need

Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific discipline
5–10+ years of experience in aseptic/sterile manufacturing
Hands-on experience in cleanroom and aseptic operations environments
Strong knowledge of aseptic processing, sterile manufacturing, contamination control, cleanroom design and operation, fill/finish operations, sterile filtration, and sterilization technologies
Experience with process validation, qualification, and GMP manufacturing systems
Familiarity with cGMP (FDA 21 CFR Parts 210/211), EU GMP Annex 1, ISO 13408, and ICH Q8/Q9/Q10 principles
Understanding of contamination control strategies and risk-based approaches
Ability to perform root cause analysis, risk assessments, and process troubleshooting
Strong data analysis and process performance evaluation capabilities
Experience with equipment commissioning and startup, process optimization and continuous improvement, and managing timelines and cross-functional deliverables
Strong project management and organizational skills
Attention to detail and strong documentation discipline
Effective communication and cross-functional collaboration
Leadership and coaching capability
Ability to travel up to 25%
Preferred: M.S. in a related scientific discipline

Benefits

Comp & perks

Comprehensive wellbeing support, retirement and financial protection benefits
Medical, dental, vision, life and disability insurance offerings
Flexible Time Off (FTO) for U.S.-based exempt employees
11 paid company holidays annually
160 hours of paid vacation annually for eligible new hires
3 optional holidays for eligible employees
Paid sick leave
Up to two paid volunteer days per year
Summer hours flexibility
Medical, personal, parental, caregiver, bereavement, or military leaves of absence
Annual Global Shutdown between Christmas Day and New Year's Day
Additional discretionary incentive cash and stock opportunities
Workplace accommodations/adjustments and ongoing support for people with disabilities