Thermo Fisher Scientific Head of Quality Control Microbiology in Plainville, Massachusetts
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary 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.
How will you make an impact?
The Head of Quality Control Microbiology provides leadership and scientific and technical expertise for Microbiology QC activities at the Plainville, Massachusetts site. As this is a brand-new site currently in construction, the manager will be integral with ensuring operational readiness of the facility, utilities, and labs to support GMP production. 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 incumbent serves as the direct supervisor of the Microbiology laboratory staff, as well as, the indirect supervisor of QC scientists and technicians, and is responsible for hiring, training, goal setting and performance evaluation. The manager will work closely with all departments and the appropriate project teams to assist in project planning and timeline development. The incumbent will plan, implement, and coordinate the improvement of QC services, considering the application of up-to-date technical, GMP and quality principles and ensuring safe environmental and working conditions in the QC Laboratories. The manager handle communications with clients as a primary technical interface between the client's technical staff.
What will you do?
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.
How will you get here?
BS required, MS preferred in a scientific/technical discipline with 8+ years of experience in a quality position within the biological and/or pharmaceutical industry.
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 leading teams in a fast-paced environment.
Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
Excellent communication skills
Ability to multitask, strategically and tactically
Solid knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
Knowledge, Skills, Abilities
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 respond to common inquiries or complaints from customers, regulatory agencies or members of the business community
Ability to effectively present information to employees, top management, public groups and/or boards of directors
Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical or diagram form
Ability to define problems, collect data, establish facts and draw valid conclusions
Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems
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
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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