Senior Director, Aseptic Process – Design

Bristol Myers Squibb

. Define and maintain the enterprise sterility and microbial failure mode library, risk classification taxonomy, contamination event typology, and risk-based sampling strategies .

Posted 9/19/2026full-timeUnited StatesSenior💰 $218,880 - $283,796 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in aseptic process design, contamination control strategies, and regulatory compliance within pharmaceutical manufacturing. Proven ability to lead cross-functional teams and drive continuous improvement in sterility assurance and microbial risk management.

Highest-signal resume keywords

Aseptic Process DesignContamination Control StrategyRegulatory Submissions/InspectionsMicrobial Risk AssessmentsEnvironmental Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Microbial Risk AssessmentFMEAFault Tree AnalysisSterilization ScienceAPS/Media Fill DesignSingle-Use TechnologiesContamination Control Risk AssessmentsHygienic Engineering StandardsQuality AssuranceBiologics Manufacturing

Soft Skills

Exceptional Scientific CommunicationCollaborative LeadershipStrategic Thinking

Tools & Technologies

Environmental Monitoring SystemsDigital/AI-Enabled AnalyticsCleanroom DesignSmoke Visualization Studies

Industry Keywords

EU GMP Annex 1FDA Aseptic Processing GuidanceICH Q9/Q10/Q11GMP EnvironmentHealth Authority Inspections

Tech Stack

Tools & technologies

Airflow

About the role

Key responsibilities & impact

Define and maintain the enterprise sterility and microbial failure mode library, risk classification taxonomy, contamination event typology, and risk-based sampling strategies
Establish and own the enterprise-wide contamination control strategy aligned with EU Annex 1, FDA Aseptic Processing Guidance, and ICH Q9/Q10
Develop and standardize risk assessment methodologies and tools across global manufacturing sites
Perform global microbial risk assessments of internal sites and build remediation action plans
Review and sign off on quality decisions impacting sterility assurance across the BMS network
Serve as escalation point for complex microbial and contamination-related quality events involving facilities, equipment, and utilities
Author technical Business Technical Assessments and inspection-ready investigation materials
Support regulatory inspections as a technical resource for FDA, EMA, PMDA, and other health authorities
Lead or support CAPA development and effectiveness monitoring for systemic contamination trends
Define and govern the enterprise APS/media fill strategy and partner with site aseptic teams
Oversee the enterprise smoke study program and review airflow outcomes in critical zones
Establish qualification and requalification frameworks for aseptic filling operations
Define manufacturing process and equipment design standards for sterilization and microbial control
Author standards for sterilization of Single-Use Technologies and consumables, including extractables/leachables and biocompatibility risk assessments
Provide hygienic equipment design leadership to Quality, Engineering, and MS&T teams
Support internal and external technology transfers with aseptic process and contamination control expertise
Coordinate microbial assessments of internal manufacturing sites and identify systemic risk areas
Conduct hygienic practice reviews of production environments and quality control laboratories
Drive continuous improvement using environmental monitoring trends, contamination investigations, and industry benchmarks
Provide aseptic and microbial control-by-design oversight for facility, utility, equipment, and process changes
Provide subject matter expertise to external manufacturers investing in new technologies
Engage in capital project, cleanroom, and major equipment design reviews
Review and approve change controls with microbial or sterility assurance impact
Drive innovation in aseptic processing, barrier systems, automation, and digital/AI-enabled environmental monitoring and trend analytics

Requirements

What you’ll need

Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
12+ years of progressive experience in pharmaceutical manufacturing, quality, sterility assurance, or microbiology within a regulated GMP environment
7+ years of senior/leadership experience with direct accountability for sterile manufacture
Expertise in aseptic process design, environmental monitoring, contamination control strategy, and regulatory submissions/inspections
Experience with Single-Use Technologies (SUT), biologics, or complex drug product manufacturing strongly preferred
Proven track record leading cross-functional teams across global, matrixed organizations
Deep knowledge of EU GMP Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10/Q11, USP, and other relevant compendia
Proficiency in FMEA, fault tree analysis, and contamination control risk assessments
Strong command of APS/media fill design, smoke visualization studies, sterilization science, and WFI/PW/utility microbiology
Familiarity with ASME BPE and EHEDG hygienic engineering standards
Exceptional scientific communication skills
Strong regulatory inspection acumen with demonstrated experience in health authority-facing roles
Collaborative, influential leadership style with ability to drive alignment across QA, MS&T, Operations, Engineering, and External Partners
Strategic thinking and ability to scale enterprise standards across a diverse global network
Willingness to travel domestically and internationally, estimated 25–35%
Advanced degree (M.S. or Ph.D.) in Microbiology or related field preferred

Benefits

Comp & perks

Additional discretionary incentive cash and stock opportunities
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 each year
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