Sr. Director, Aseptic Process & Design

Key Responsibilities
Enterprise Risk Framework & Taxonomy

• Define andmaintaintheenterprise sterility and microbial failure modelibrary, including risk classification taxonomy, contamination event typology, and risk-based sampling strategies

• Establish and own theenterprise-wide contamination control strategy(CCS)aligned with current regulatory expectations (EU Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10)

• Develop and standardize risk assessment methodologies and tools used across global manufacturing sites

Risk Assessment Governance & Quality Oversight

• Perform Global Microbial risk assessments of the internal sites and help build action plans with the sites to remediate risk.

• Provide authoritative review and sign-off on quality decisions thatimpactsterility assurance across the BMS network

• Serve as the enterprise escalation point for complex microbial and contamination-related quality eventsaround Facilities, Equipment and Utilities

Technical Authorship & Regulatory Inspection Support

• Author technical Business Technical Assessments (BTAs)and develop robust investigation and inspection-ready materials in support of systemic microbiological issues

• Serve as a key technical resource during regulatory inspections (FDA, EMA, PMDA, and others), providing expert testimony and documentation on aseptic process and microbial control matters

• Lead or support CAPA development and effectiveness monitoring for systemic contamination trendsaround Facilities, Equipment,andUtilities

Aseptic Process Simulation (APS) & Media Fill Governance

• Define and govern the enterprise APS/media fill strategy, including program design, intervention criteria, acceptance expectations, and performance governance. Partnering with aseptic teams at the sites.

• Oversee the enterprisesmoke study program, including design, execution standards, and review of outcomes to confirm airflow behavior in critical zones

• Establish qualification and requalification frameworks for aseptic filling operations

Manufacturing Process & Equipment Design Standards

• Define manufacturing process and equipment design standardsfor sterilization and microbial control, including terminal sterilization, filtration sterilization, and SIP/CIP processes

• Provideexpertiseand author standards forsterilization of Single-Use Technologies (SUT) and consumables, including extractables/leachablesconsiderations and biocompatibility risk assessments

• Provide hygienic equipment design leadership to Quality, Engineering, and MS&T teams, ensuring robust contamination control by design

• Provide aseptic process and contamination controlexpertiseto support Internal & External technology transfers

Site Microbial Assessment Ownership

• Own and coordinate the microbial assessment of internal manufacturing sites, ensuring consistent application of enterprise standards and identification of systemic risk areas

• Conducthygienic practice reviewsof production environments and quality control test laboratories

• Drive continuous improvement initiatives based on environmental monitoring trend data, contamination investigation findings, and industry benchmark intelligence

By-Design Oversight for Changes & Capital Projects

• Provideaseptic and microbial control by-design oversightfor facility, utility, equipment, and process changes 6 for both sterile and non-sterile manufacturing sites

• Provide subject matterexpertiseat external manufacturers when investing innew technologies

• Engage at the design review stage of capital projects, cleanroom construction/renovation, and major equipment installations to embed contamination control principles frominception

• Accountable for reviewing and approving change controls with microbial or sterility assurance impactduring design or critical changes in a facility

• Drive innovation in aseptic processing technologies including advanced barrier systems, automation and digital/AI enabled environmentalmonitoring and trend analytics

Qualifications & Experience
Education

• Required:Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline

Experience

• 12+ yearsof progressive experience in pharmaceutical manufacturing,quality, sterility assurance, or microbiology within a regulated GMP environment

• 7+ yearsof senior/leadership experience with direct accountability for sterile manufacture

• Demonstratedexpertiseinaseptic process design, environmental monitoring, contamination control strategy, and regulatory submissions/inspections

• Experience withSingle-Use Technologies (SUT), biologics, or complex drug product manufacturing strongly preferred

• Proventrack recordleadingcross-functional teamsacross global, matrixed organizations

Technical Expertise

• Deep knowledge ofEU GMP Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10/Q11, USP <1116>, <797>, and other relevant compendia

• Proficiencyinrisk management tools(FMEA, fault tree analysis, contamination control risk assessments)

• Strong command ofAPS/media fill design, smoke visualization studies, sterilization science, and WFI/PW/utility microbiology

• Familiarity with hygienic engineering standards (ASME BPE, EHEDG)

Leadership & Competencies

• Exceptionalscientific communication skills 6able to translate complex microbiological risk into clear, actionable guidance for diverse audiences including senior leadership and regulators

• Strongregulatory inspection acumenwithdemonstratedexperience in health authority-facing roles

• Collaborative, influential leadership style with the ability to drive alignment across QA,MS&T,Operations, Engineering, and External Partners

• Strategic thinker with the ability toscale enterprise standardsacross a diverse global network

• Willingness totravel domestically and internationally(estimated 25 635%) to manufacturing sites and third-party partners

Preferred

• Advanced degree (M.S. or Ph.D.) in Microbiology or a related field



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We hire for skills and capabilities, not just credentials 6 if this role excites you, but doesnt perfectly match your resume, we encourage you to apply anyway.