Responsibilities

• Performing, managing, and enhancing the safety testing of final drug products, including but not limited to sterility, endotoxins, mycoplasma, in accordance with compendial methods
• Establish, validate, and sustain the environmental monitoring program
• Support EMPQ of the control cleanroom activities
• Manage the validation of rapid release microbiological methods in accordance with USP <1223>, used in QC as well as the transfer and validation of methods to contract testing laboratories
• Collaborate with QC Analytical management in establishing product specifications
• Subject matter expert on investigations of microbiological methods and environmental monitoring
• Subject matter expert on Contamination Control Program
• Assemble and report quarterly, annual, and customized trend reports for environmental monitoring, personnel monitoring, excursions, and out of trend data in support of continuous improvement
• Assemble and report contract laboratory testing data 
• Complete routine record and test data review
• Develop, revise, and review SOPs, qualification/validation protocols and reports
• Conduct investigation regarding out of specifications (OOS) results and address and manage deviations related to microbiology procedures
• Establish user requirements for purchase of new Cellares GMP equipment
• Behaves as a working backup QC analyst for testing activities as needed
• Assist in the preparation of dossiers and data packages in support of Cellares products for regulatory agencies
• Manage and grow a phase appropriate team of Quality Control Microbiology personnel, including training QC analysts to perform laboratory procedures and assays
• Serve as Quality Control representative during cross functional project meetings
• Establish and promote an environment that supports the Quality Policy, Data Integrity and Quality System
• Other duties as assigned

Requirements

• Bachelor’s degree in Biology, Microbiology, or other laboratory-based life science; or equivalent combination of education and experience.
• 7+ years experience in a GMP environment with knowledge of cGMP regulations and a background in microbiology
• 2+ years experience leading and developing a team, preferably within a quality environment
• Strong technical knowledge in various microbiological techniques including rapid release methods, environment qualifications, and cellular therapy based products
• Experience in the application of microbiological techniques such as air monitoring, surface monitoring, and genus and species identifications
• Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211, and EU Annex 1, relevant USP/EP methods, and other global regulatory microbiological methods, as applicable
• Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, microbiological testing, and auditing
• Identifying, authoring, and supporting OOS, DRs, and CAPAs
• Equipment IQ/OQ/PQ experience
• Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
• Excellent interpersonal, verbal, and written communication skills
• Comfortable in a fast-paced environment with minimal direction and able to adjust to a dynamic work environment
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset