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Head of QC Microbiology

Thermo Fisher Scientific Inc.
North Amherst, Massachusetts, US
Closing date
Jan 30, 2022

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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Job Description Job Title: Head of Quality Control, Microbiology Requisition ID: 176255BR When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale. Join 80,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information Cambridge, MA/Bio Manufacturing, Viral Vectal Services How will you make an impact? The Head of Quality Control, Microbiology is responsible for overseeing all cGMP Microbiology testing including environmental monitoring for Brammer Bio manufacturing facilities. This individual will be a key member of the management team and will be responsible for the design, implementation, and continuous improvement of all processes/systems in support of the Bio Manufacturing plant and its utilities. In addition, the he/she will be responsible for developing and executing Brammer bio's quality policies, practices, procedures standards, and systems necessary to ensure adherence to aseptic production and product management in accordance to the cGxP compliance to US and EU regulations. What will you do? Scale of Responsibilities * Oversee the overall Quality Control Microbiology laboratory strategy and operation, with a concentrated focus on facility utilities, environmental classification and control design, program design for Microbiology laboratory equipment, and facility qualification/control. * Oversee the Aseptic Gowning and Training Program. * Maintain a robust Environmental Monitoring program that meet US/EU and other applicable regulatory requirements. * Organize and direct cross functional relationships with Manufacturing, Engineering, MS&T, Quality Assurance, and Regulatory. * Organize and direct cross functional relationships with Manufacturing, Engineering, MS&T, Quality Assurance, and Regulatory. * Hire staff and manage contract vendors for programs related to the QC Microbiology laboratory. * Direct laboratory staff, set goals and expectations, and maintain efficient utilization of resources. * Author and approve documents required for regulatory submissions. * Develop, implement and enforce Microbiology laboratory procedures and policies. * Ensure continued professional development of staff through training and functional interactions with various operating groups. * Provide presentations, explain laboratory qualification and operations, and defend testing results during FDA and other inspections. * Liaison with other departments as needed to ensure timely flow of samples and communicate any delays in testing, particularly project managers. * Manage team of Analysts and associated Supervisors How will you get there? Education * . BS/MS in Microbiology discipline Experience * 12+ years of experience in a cGMP microbiology testing laboratory environment preferred, with strong knowledge of regulatory, USP and Eur. PHr guidelines as related to Microbiology issues, aseptic processing, and bio-safety. * Experience leading teams required. * Experience in gene therapy analytical testing and development is recommended. Knowledge, Skills, Abilities * Detail oriented and the ability to communicate effectively, proactively and professionally to clients and members of the management team. * Skilled in use of Microsoft Outlook, Powerpoint, Word, Excel and Project programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English. At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. * This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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