The Role:

The Specialist II, QC Microbiology will perform assay development, characterization, optimization, transfer, qualification, verification, validation and investigation for QC Microbiology group. The role will provide technical support and guidance related to environmental monitoring, release, stability, and in-process testing and method development. This role will train staff, support laboratory/cleanroom start-up and qualification, and support that the company’s sterility assurance and contamination control strategies are compliant with current industry and regulatory standards. In addition, this role will work cross-functionally with Quality Assurance and Manufacturing to support the production of cell and gene therapy products through safety testing, environmental monitoring testing and supporting investigations.

Here’s What You’ll Do:

• Ensure consistent execution of microbiological method transfer, qualification, verification, and activities, supporting internal and client programs.
• Facilitate improvements for microbiological methodologies, techniques, equipment, instruments, and capabilities for microbiological testing, cleanroom environmental monitoring, personnel, facility & utility monitoring.
• Collaborate with Analytical Development on new and rapid microbiological test methodologies.
• Support setting of product specifications, process control strategies, environmental alert and action limits.
• Serve as key subject matter expert for Contamination Control and Sterility Assurance programs
• Interpret microbial identifications and provide microbial impact assessments related to investigations
• Participate in risk assessments related to aseptic and microbiological environmental controls
• Participate in technical troubleshooting and investigations.
• Review analytical development reports, test method and process qualification reports and other technical documents for technical correctness and regulatory compliance.
• Develop, deliver and coach on theory, technical and aseptic training for analysts, operators and technicians.
• Assist in the generation, review and approval of protocols, reports, and CofAs.
• Prepare, evaluate, and present data internally to cross functional teams.

Requirements:

• S. (M.S. preferred) in Microbiology with 6+ years relevant experience.
• Strong communication, interpersonal and organizational skills
• Ability to work with others to resolve complex technical and scientific problems
• Advanced knowledge and technical proficiency, ability to solve complex issues independently
• Demonstrated GMP compliant and thorough laboratory study documentation experience
• Experience performing laboratory and/or manufacturing investigations.
• Experience in GxP requirements of biopharmaceutical manufacturing and testing
• Experience with aseptic processing and clean room operations per ISO 14644.
• Experience with compendial safety testing (e.g. bioburden, mycoplasma, endotoxin and sterility) including rapid methodologies (e.g. BacT Alert, Milliflex, PCR, NGS, etc.).
• Experience in statistical analysis and visual data presentation is desirable.
• Experience in cell therapy manufacturing, or human cell, tissue, and cellular and tissue-based products (HCT/P) is desirable.
• Familiarity or experience with medical microbiology, clinical microbiology, or healthcare setting microbiology is desirable.