Sterility Assurance Lead, CVRM (Holly Springs)

Welcome to Holly Springs North Carolina home to Roche/Genentechs largest-ever investment: a $2B greenfield start-up where next-generation technology high-performing teams and Operational Excellence converge to create the global standard for high-volume highly-efficient Drug Product manufacturing.

The facilitys core is defined by Innovation - leveraging advanced automation robotics digital tools real-time data analytics and simple streamlined processes to produce the highest quality medicines. This plant meets todays demand for CVRM (Cardiovascular Renal and Metabolism) medicines and is scalable to grow with the portfolio which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced entrepreneurial environment with a high-level of accountability with planned launch in 2028.

Are you a problem-solver and change-agent who thrives in a Team environment eager to tackle the most complex manufacturing challenges If so this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.

Join us in Holly Springs where you wont just build a plantyou will build the future of medicine.

The Opportunity

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.

What Youll Do

• 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.

Who You Are

• Bachelors degree in Microbiology Biology Chemical Engineering or a related scientific discipline. A Masters 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.

• Prior experience in the commissioning qualification and start-up of a new (greenfield) or substantially renovated sterile manufacturing facility is highly desirable.

• 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.

Relocation assistance is available for this role.

The expected salary range for this position based on the primary location for this position of Holly Springs North Carolina is $141200 - $262200. Actual pay will be determined based on experience level qualifications geographic location and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Link to Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.