QC Supervisor - Cell Therapy (2nd Shift)
Company: Thermo Fisher Scientific
Posted on: November 22, 2021
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 Supervisor, QC role reports to the Manager QA of Cell Therapy
and will oversee the Technology Transfer of methods for new
products, verification, qualification and daily testing of methods
in support of Manufacturing Operations for second shift activities.
The Supervisor, QC works in close collaboration with Operations,
Clients, and (senior) scientists from Process Development (PD) and
* What will you do? *
* This position ensures that all testing processes and departmental
documentation meet Patheon - Princeton, NJ and cGMP regulatory
* 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 - during second shift.
* This position is expected to be one of the QC Leads for state of
the art cell therapy unit. As a leader for the site, 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 Quality Head.
* Oversees, manages, and ensures the successful day-to-day
operations of Quality Control departments for the company on the
second shift. The Supervisor, QC ensures this success of the teams
by direct management of the individual contributors within the QC
* Actively take the lead in ensuring GMP compliance for the
company. Set strategy in investigations and CAPAs, as
* 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).
* 5+ years prior supervisory experience 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
* Ability to create, use and interpret scientific tables, charts,
* 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
* Solid understanding of applicable regulatory requirements.
* Ability to understand, create, maintain, and deliver on
* 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.
Keywords: Thermo Fisher Scientific, Trenton , QC Supervisor - Cell Therapy (2nd Shift), Hospitality & Tourism , Princeton, New Jersey
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