Sterility Assurance Lead
RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.
For more information, visit www.resilience.com.
Position Summary & Role:
This role is accountable for assisting in the development and oversight of the implementation of the microbial contamination control and viral safety programs at Resilience. This is an exciting opportunity to contribute to the establishment of a robust and comprehensive contamination control program. This role will collaborate with multiple stakeholders to ensure the harmonized execution of contamination control policies across the Resilience network. This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods. The Sterility Assurance Lead is a key support role and reports to the Head of Global Microbial Contamination Control & Viral Safety.
The position will be an onsite position in West Chester, OH.
- Championing sterility assurance principals at the site and serving as the microbial control site technical leader in the areas of aseptic processing, contamination control and viral safety.
- Support the site compliance to the global microbial/viral control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, cleanroom management, microbiological methods and validations including RMM, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments
- Ensure alignment and harmonization regarding global microbiological/aseptic standards and compendial/regulatory requirements
- Responsible for establishing and maintaining the site Contamination Control Strategy (CCS) and management of the gap assessments and risk assessments related to Annex 1 and CCS compliance
- Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial/viral controls
- Lead site microbial and cross contamination LOPA and HACCP risk assessments
- Participate in site Contamination Control Review Committee (CCRC) meetings as the Sterility Assurance SME
- Act as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological and viral safety testing including Rapid Microbial Methods (RMMs), ensuring alignment with the global micro strategy
- Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records
- Support inspection readiness plans and interact with regulatory agencies during inspections on Microbial Contamination Control and Viral Safety program related matters
- Provide microbial SME support for microbial investigations and microbiological/aseptic related challenges to the Resilience network
- Lead efforts, in collaboration with other site and company experts, to ensure compliance and adequate cleanroom design, airflows, traffic flows, cleaning and disinfection, aseptic gowning, aseptic techniques and behaviors.
- Actively participate in industry forums such as PDA, ISPE, BPOG, etc. to lead external engagement and benchmark industry trends and standards
- Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field
- Minimum of 7+ years of pharmaceutical or biotechnology industry experience, with minimum of 4+ years in a microbial contamination control role.
- Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology
- Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy required
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required
- Experience with microbiological risk assessments
- Comprehensive knowledge of global GMP regulatory requirements for biologics and/or cell & gene therapy products
- Excellent oral and written communication skills with strong technical writing experience required
- Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders
- Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
- Knowledge and familiarity with Annex 1
- Background in Microbiology
- Risk Assessment facilitation
- Experience in tech transfer
- Contamination Control strategy experience