When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
*How will you make an impact?*
The QC Scientist III role is to oversee the Technology Transfer of methods and daily testing of such methods in support of Manufacturing Operations. This role is part of the QC team which is responsible for managing and implementation of customer-driven technology projects within the QC department. The QC Scientist III works in close collaboration with QC supervisors, Operations, Clients, Management and (senior) scientists from Process Development (PD) and QA (compliance) managers.
*What will you do? *
* This position ensures that all testing processes and departmental documentation meet Patheon - Princeton, NJ and cGMP regulatory standards.
* This position is responsible for managing and coordinating the safety, quality, execution, and continuous improvement activities of the Quality Control department. This includes sampling, testing, and inspecting products, stability samples, facility samples, and raw materials in order to ensure compliance with quality standards and production schedules.
* This position is expected to be one of the QC Lead Analysts for our new state of the art cell therapy unit. As a leader for the team, this individual will exhibit leadership traits and characteristics and be perceived by not only his/her group as a leader, but also by the site when Quality Control issues arise around the site. This will be accomplished by ensuring the following responsibilities are met, and by ensuring a strong Quality culture is maintained throughout the QC portions of the facility in cooperation with the aims and direction of the Site Leadership team.
* Actively take the lead in ensuring GMP compliance for the company. Set strategy in investigations and CAPAs, as necessary.
* Participate and/or lead meetings, to provide input on timelines, potential compliance issues and other related QC activities.
* Provide overall departmental feedback to Quality Head.
*How will you get here?*
* A BS or BA with 8-10 years of relevant experience.
* MS in Biochemistry, analytical chemistry, or related field plus 6-8 years of relevant experience.
* Ph.D. in Biochemistry, analytical chemistry, or related field plus 5-6 years of relevant experience.
* 8 years of experience in Quality Control of biopharmaceuticals (experience in a GMP environment preferred).
* Lean labs understanding is a requirement
* Proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Quality Management System (QMS) software), including software programs generating reports and statistics.
* Ability to create, use and interpret scientific tables, charts, and graphs.
* Extensive knowledge of general and specific QC analytical testing principles which support Cell Therapy testing such as Flow Cytometry, Cell Counting, ELISA, etc. as applicable to focus of position (e.g., raw materials, chemistry, microbiology, etc.).
* Knowledge of testing and associated equipment protocols and requirements and analytical instrumentation.
* Strong interpersonal and communications skills; written and oral.
* Solid understanding of applicable regulatory requirements.
* Ability to understand, create, maintain, and deliver on budgets.
* Extensive knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. Applies GMP regulations and other international guidelines to all aspects of the position.
* Ability to work with the goals and objectives of the Quality Head and translate them into actionable work for staff to meet those goals and objectives.
* Ability to create and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees. Able to coach and mentor more junior employees to success.
* Ability to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.
* Ability to manage performance of people.
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.