Manager, Quality Control - MicrobiologyCognate BioServices - Memphis, TN
About the Job
Cognate currently has an opening in the Quality Control Microbiology Department and is seeking a talented individual. At its core, the position requires a strong working knowledge of and experience with regulatory requirements for Environmental Monitoring of GMP cleanrooms including how to appropriately and effectively complete investigations of excursions, familiarity with compendial microbiological safety testing methods and requirements common to the pharmaceutical industry for sterility, mycoplasma, endotoxin, etc., and experience with culturing and identifying various microorganisms (bacteria, yeast, fungi) by different methods (stains, PCR, etc.).
Additional Job Requirements:
- Previous experience managing/scheduling staff for a 24/7 operation.
- Experience with microbiology laboratory design requirements, set-up/equipping, and inventorying.
- Familiarity with state-of-the-art methodology for rapid detection of microbial contamination and/or identification (BacT/ALERT, Milliflex, MICROSeq, etc.)
- Experience with media and microbe qualification testing in support of EM and/or sterility testing.
- Experience with PCR-based mycoplasma detection assays and validation of such according to pharmacopeial (e.g. EP) guidelines
- Study design, data/statistical analysis, reporting results in both written and oral format (presentation).
- An expansive understanding of cGMP/GLP regulations as well as excellent documentation skills in order to complete paperwork dealing in all aspects of Quality Control.
- Familiarity with basic core QC areas including product/material stability, trending, comparability, qualification/validation, compendial methods, etc.
- Excellent writing skills. Experience in drafting of Standard Operating Procedures (SOPs), protocols, reports, etc.
- Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies in general and the environmental monitoring and operation of cleanrooms, specifically.
- Excellent interpersonal skills and willingness to work interdepartmentally with QC, Manufacturing and Quality Assurance.
- Ability to problem solve and troubleshoot as necessary.
- MS or PhD with 5-7 years of relevant Microbiology experience.
- Experience performing and managing performance of Environmental Monitoring of GMP cleanrooms (scheduling and staff, etc.).
- Knowledge of ISO regulations specific to GMP cleanrooms and a good understanding of USP, EP guidelines associated with cell therapies/ biologic.
- Experience in CAPA and troubleshooting.
- Ability to process large amounts of paperwork in a timely and efficient manner.
- Ability to work in a team-oriented, multidisciplinary and multicultural environment.
- Ability to work flexible hours to meet the deadlines.
- Ability and desire to take initiative on department-wide improvement projects and drive to completion.
8 days 23 hours ago
Please review all application instructions before applying.
About Cognate Cognate is a dynamic organization focused on providing a broad range of commercialization services to regenerative medicine and advance cell therapy organizations. Cognate provides specialized services to companies across all points of clinical and commercial development ranging from early preclinical studies through commercial manufacturing. Cognate applies the expertise of its business, scientific and technical teams to successfully develop biotechnology products across multiple cell-based technology platforms from start to finish. Employees are our most valuable resource. We are committed to fostering an environment where innovation, teamwork, communication, and recognition are encouraged and rewarded. Cognate offers a competitive base salary, tuition reimbursement, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, prescription, FSA, short/long term disability, life, voluntary life and 401(k). Cognate is an equal opportunity employer that values diversity at all levels.
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