Sterility Assurance Lead

Genentech•Cary, NC

3d•Onsite

About The Position

We are seeking a highly motivated and experienced Sterility Assurance Director. This role is strategic and highly impactful, ensuring every patient benefits from medicines produced under the highest possible standards of quality and compliance. You will serve as the primary point of contact for Sterility Assurance at the site, partnering with MSAT, Operations, Quality, QC, Engineering, as well as Global teams, to ensure adherence to stringent standards. This critical role involves building the entire sterility assurance framework from the ground up, covering everything from design and commissioning through routine commercial operations. This ensures all processes, equipment, and facilities meet global regulatory requirements (FDA, EMA, etc.) and industry best practices, proactively embedding "sterility by design" into future work.

Requirements

Bachelor’s degree in Microbiology, Biology, Chemical Engineering, or a related scientific discipline. A Master’s or PhD in a biological science is preferred.
12+ years of increasing responsibility within Quality Assurance or Microbiology in the pharmaceutical or biotechnology industry, with at least 5 years dedicated to Sterility Assurance in an aseptic manufacturing environment.
Deep technical understanding of sterility assurance from both scientific and compliance perspectives, including aseptic processing fundamentals, cleanroom behavior, environmental monitoring basics, and contamination control principles.
Must be current in technological and compliance developments across the parenteral manufacturing industry.
In-depth expert-level knowledge of global regulations, guidance, best practices, and industry standards related to sterility assurance, including cGMPs, GLPs, FDA requirements, and EU Annex 1 expectations.
Proven expertise in designing and managing Aseptic Process Simulation programs and qualification requirements for isolators and process support equipment.
Demonstrated ability to strategically influence facility design and process flows from a sterility assurance perspective.
Exceptional leadership, communication, and collaboration skills, with the ability to make persuasive recommendations based on rational analysis.
Proven ability to lead without direct authority and demonstrated experience influencing site and network leaders to advance technical agenda projects.
Excellent ability to network internally and externally,
Ability to mentor and develop teams in sterility assurance and applied pharmaceutical microbiology, including coaching and mentoring capabilities for shopfloor training and education.
Proficiency in critical decision-making, complex problem-solving, and strong scientific/practical thinking to evaluate options and select the best path forward.

Nice To Haves

Prior experience in the commissioning, qualification, and start-up of a new (greenfield) or substantially renovated sterile manufacturing facility is highly desirable.
A Master’s or PhD in a biological science is preferred.

Responsibilities

Sterility Assurance Strategy Development: Support the establishment and implementation of the comprehensive Contamination Control Strategy (CCS) for the new facility, aligning to the global CCS standards and focusing on aseptic processing, sterilization methods, sanitization, and end-two-end facility design controls.
Sterility by Design: Establish and implement robust sterility assurance standards (SOPs and standard work) throughout the business and operational activities. Drive continuous improvement by regularly assessing and refining processes and procedures to maximize efficiency and effectiveness.
Design & Commissioning Phase: Review and approve facility and equipment design specifications related to aseptic processing zones, air classifications, and material plus personnel flows to ensure inherent to site wide contamination control strategy.
Technical Expert & Problem Solver: Act as a subject matter expert and provide guidance on matters related to sterility assurance and environmental monitoring, monitoring data and trends and identifying areas for improvement
Root Cause Analysis: Lead complex microbiological investigations (e.g., sterility failures, high EM excursions, APS failures), determining root causes and ensuring the implementation of effective Corrective and Preventive Actions (CAPA).
Training and Compliance: Develop and deliver specialized training programs for manufacturing and quality personnel on aseptic techniques, gowning qualification, and cleanroom behaviors.
Materials Qualification: Establish requirements for the qualification of critical raw materials, components, and single-use systems to ensure compliance with microbiological specifications and cGMP requirements.
Aseptic Program Leadership: Oversee the design, execution, and final approval of the Aseptic Process Simulation program, site Contamination Control Strategy and ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory expectations.
Validation Oversight: Provide sterility assurance expertise for the qualification and validation of critical systems, including clean utilities (e.g., WFI, clean steam), sterilization equipment (e.g., autoclaves), isolators, and environmental monitoring systems. Oversee the development, qualification and validation of robust sterilization cycles for all manufacturing process components, equipment, and all critical product contact parts.
Environmental Monitoring: Define and implement the Environmental and Personnel Monitoring program, including action/alert limits, investigation procedures, and data trending/analysis.
Regulatory Readiness: Serve as the subject matter expert during dossier preparation and regulatory inspections regarding all aspects of sterility assurance and contamination control.
Support Strategic Consistency: Represent the site and assume SME leadership role for specific topic areas within the global Aseptic Processing Community and Environmental Monitoring Teams, build strong partnerships with other sterile DP sites, support harmonization and knowledge sharing.
External Influence: Benchmark industry trends and regulatory guidance, represent the company in meetings, conferences, and industry events, and assess new technologies for currency with industry best practices.