Cognate BioServices, founded in 2002, is a contract manufacturing organization dedicated to serving customers engaged in but not limited to the development and commercialization of novel cellular and gene therapy applications.
Job Title: Senior Analyst, Quality Control, Microbiology
Cognate is currently seeking a Microbiologist in the Microbiology division of the Quality Control department. The successful candidate will be responsible for microbial strain analysis using classical and state-of-the art microbiological methods. Experience with culturing and identifying various microorganisms such as bacteria, yeast, fungi by different methods such as Gram stain and PCR are key to this position. This position will require occasional environmental monitoring of GMP cleanrooms. Attention to detail, strong organizational skills, computer proficiency and being able to work in a team is important for this position. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.
• Experience in microbiology laboratory techniques (classical, biochemical, Gram’s staining and such).
• Familiarity with state-of-the art methods (BacT/ALERT, Milliflex, MICROSeq, etc) for rapid detection of microbes.
• Experience in PCR based assays.
• Experience in Microsoft Word, Excel and PowerPoint.
• Experience in data/statistical analysis, reporting results in written reports and oral presentations.
• Excellent writing skills. Experience in drafting protocols and reports.
• Familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with quality control of cell therapies and cleanrooms.
• Occasionally performs environmental monitoring in the GMP cleanrooms.
• Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability.
• Responsible for routine laboratory upkeep and organization.
• Receives raw materials and supplies for the QC laboratory.
• Maintains laboratory supplies, media and reagents inventory.
• Excellent interpersonal skills and willingness to work in a team.
• Ability to problem solve and troubleshoot.
• Masters or higher degree in Microbiology with 5 years of relevant Microbiology experience.
• Previous supervisory experience preferred.
• Experienced in Microbiology and aseptic techniques.
• Detail-oriented with strong written and verbal communication skills.
• Ability to problem-solve and troubleshoot as necessary.
• Ability to work independently or as a team member.
• Training and supervising analysts in microbiology techniques and methods.
• Must be able to fully gown-up for aseptic environment work.
• Must be able to occasionally work on weekends.
• BacT Alert
• Laser particle counters
• Viable air samplers
• Endosafe® Instrumentation
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Closing Date 07-31-2017
Cognate BioServices, Inc., in conformity with applicable laws, is an Equal Opportunity Employer and does not discriminate on the basis of race, color, sex, sexual orientation, age, religion, national origin, or disability.