Quality Control Microbiology – Manager

The clinet is seeking a talented individual with strong working knowledge and experience in cell culture and microbiology. SME with excellent troubleshooting, training and presentation skills. Familiarity with regulatory requirements for microbiological testing of in-process and finished cell lines. Knowledge of 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.
- 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.
- Previous training experience and excellent presentation skills.
- Ability to problem solve and troubleshoot as necessary.
Applicant Requirements:
- MS or PhD with 5-7 years of relevant Microbiology experience.
- Experience managing scheduling and performance of staff.
- Ability to troubleshoot contamination in in-process and finished product.
- 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.