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Job Details

Senior Manager QC Microbiology 993915

Location
Cambridge, MA, United States

Posted on
Aug 12,2019

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Job Scope & Purpose: Our well-funded Greater Boston based client is seeking a Senior Manager to lead its cGMP microbiology laboratory and staff. This individual will establish the QC Microbiology function, overseeing laboratory/clean room start-up and qualification, the hiring and training microbiology staff, the development of the environmental monitoring program and contamination and control strategies. This hire will also oversee routine microbiology testing and present periodic trending reports to leadership.  This is a position not to be missed - reach out to Todd Jamison or Kevin Rees for more information!     Primary Job Responsibilities:? Develop and implement environmental monitoring and contamination control strategies using risk analysis Oversee routine environmental monitoring and safety testing of viral vector and cell and gene therapy drug products, ensuring that all work is carried out per cGMPs and applicable policies and procedures Review, trend and present EM data to senior management quarterly Review and approve microbiology laboratory SOPs, protocols and reports Oversee microbiology laboratory excursions, including; deviations, OOS, OOT and atypical investigations  Participate in regulatory inspections and facility audits Hire, train and mentor microbiology staff Primary Job Requirements: Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of seven years of experience in a GMP Quality Control microbiology lab setting Experience with clean room qualification per ISO 14644 Experience with compendial safety testing as well as rapid methodologies (BacT) Ability to communicate and work independently with scientific/technical personnel. Strong knowledge of GMP, SOPs, and quality system processes.   Excellent organizational skills. Experience in cell and gene therapy manufacturing environment a plus Experience performing laboratory investigations About **MEMBERS ONLY**SIGN UP NOW***.: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each **MEMBERS ONLY**SIGN UP NOW***. team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a **MEMBERS ONLY**SIGN UP NOW***. team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ **MEMBERS ONLY**SIGN UP NOW***. is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. **MEMBERS ONLY**SIGN UP NOW***. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.,

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