Job Description

　　As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to 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

　　This position will be site based in Plainville, MA and will support our Viral Vector Services (VVS Plainville) business unit of Thermo Fisher Scientific. At VVS Plainville, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

　　Discover Impactful Work:

　　The Manager of Quality Control Microbiology provides leadership and scientific and technical expertise for Microbiology QC activities at the Plainville, Massachusetts site. These activities include the timely qualification of in-process and release testing of commercial grade biopharmaceuticals, qualification/validation of the facility and utilities, qualification of methods for support of vector cGMP compliant Manufacturing and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory. The manager is also responsible for maintaining cGMP compliance in his/her areas of responsibility and for operating within project and department budgets. The manager handle communications with clients as a primary technical interface between the client’s technical staff.

　　A Day in the Life:

　　Oversee and drive the Microbiology lab operational readiness plan to ensure on time approval of analytical equipment and test methods needed for GMP testing.

　　Build a trained competent team of QC analysts to support GMP testing.

　　Once the labs are operational, oversee the day-to-day Quality Control activities for environmental monitoring, bioburden, and endotoxin testing. Seeks the highest level of compliance, accuracy and timeliness of specified testing processes. Leads efforts around bringing in new technology, equipment, methodologies and associated validations. Provides QC leadership, guidance and support throughout the VVS organization. Works cross functionally and ensures good communication across the network. Ensures all testing processes, metrics and departmental goals are met.

　　Strives to implement and improve systems and drive efficiency throughout the organization.

　　Supports internal, external and regulatory inspections as needed. Manages team of managers and professionals within Quality. Hires and develops employees within the department. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.

　　Serves as primary QC Microbiology contact for regulatory inspections and client audits.

　　Support establishment and/or enhancement of QC and operational metrics.

　　Lead, and/or support establishment of electronic LIMS systems for site.

　　Provides frequent overall departmental feedback to senior management.

　　Ensure adequate staffing is hired and trained in the QC Microbiology department.

　　Keys to Success:

　　Education

　　BS in sciences, or related field required.

　　MS preferred in a scientific/technical discipline is preferred.

　　Experience

　　6 years of experience in a quality position within the biological and/or pharmaceutical industry, or highly regulated field.

　　PhD in a scientific/technical discipline a plus.

　　Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS) preferred.

　　Experience with writing Deviations, Lab investigations and OOS required; experience with Root Cause Analysis required.

　　Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.

　　Knowledge, Skills, Abilities

　　Excellent communication skills.

　　Ability to multitask, strategically and tactically.

　　Solid knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.

　　Ability to write reports, business correspondence and procedure manuals.

　　Strong organizational skills: ability to prioritize and manage through complex processes/projects.

　　Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, financial reports, governmental regulations and legal documents.

　　Ability to deal with abstract and concrete variables in situations where only limited standardization exists.

　　Ability to utilize various standard programs for data entry and word processing.

　　Ability to utilize software and customized programs to meet business needs.

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Apply today! http://jobs.thermofisher.com

　　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

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　　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.