- 187264 - QC Scientist III
- NJ-New Jersey
- 12 Months
- Chipton-Ross is seeking a QC Scientist III for an opening in Princeton, NJ.
The QC Scientist III role is to oversee the Technology Transfer of methods and daily testing of such methods in support of Manufacturing Operations. The QC team is responsible for managing and implementation of customer-driven technology projects within the QC department. The QC Scientist III works in close collaboration with supervisors, other Engineers, line management and (senior) scientists from Process Development (PD) and QA (compliance) managers.
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 ensures that all testing processes and departmental documentation meet Patheon – Princeton, NJ and cGMP regulatory standards.
This position is expected to be the QC Lead for our new 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.
The Sr. Manager of QC ensures this success of the teams by oversight of the Managers (or possibly Managers and Supervisors) of the functional groups. Direct management of the individual contributors may occur on a limited basis as well.
12+ years of experience in a GMP environment, with a minimum of 8 years of experience in Quality Control of biopharmaceuticals.
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.
Knowledge, Skills, Abilities:
Extensive knowledge of general and specific QC analytical testing principles, 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.
Knowledge of method qualification, method transfer, and assay development.
Extensive knowledge of Flow Cytometry, Elisa, Gram Stain, qPCR, and Cell Culture.
Strong interpersonal and communications skills; written and oral.
Solid understanding of applicable regulatory requirements.
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.
Actively take the lead in ensuring GMP compliance for the company. Set strategy in investigations and CAPAs, as necessary. Ensure follow up.
Participate and/or lead meetings, to provide input on timelines, potential compliance issues and other related QC activities.
Provide overall departmental feedback to Site Quality Head.
Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, Protocols, etc.
Able to indirectly manage performance of people through direct reports.
Accredited Ph.D. in Biochemistry, analytical chemistry, or related field plus a minimum of 6 years of relevant experience. MS in Biochemistry, analytical chemistry, or related field plus a minimum of 8 years of relevant experience. A BS or BA with a minimum of 10 years of relevant experience.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.