Job Description

When you are part of the team at Thermo Fisher Scientific, youll 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 youll be supported in achieving your career goals.

Location/Division Specific Information

Princeton New Jersey/ Pharma Services Division

How will you make an impact?

The QC Scientist II Cell Therapy role will be responsible for the performance of tasks in support of the manufacture of Clinical Cell Therapy Manufacturing process. They will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to the microbiological testing including management of environmental monitoring samples and execution of analytical related testing on in process, release, and stability samples,. These functions may include but are not limited to activities such as Flow Cytometry, ELISA, review of data generated reports, authoring protocols in accordance to industry standards, site SOPs and policies.

What will you do?

* Assist in all Department functions, such ordering of supplies, equipment, logbooks and data in accordance with site SOPs and policies.
* Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.
* Interpret data results in accordance to concepts of microbiology, industry standards, and site SOPs and policies.
* Serve as Analytical SME reviewer and approver for minor/major deviations (when delegated).
* Participate in investigation/RCA for OOSs/investigations.
* Critical evaluation of processes, including foresight and thinking ahead.
* Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.
* Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly.
* Identify deviations and aid in investigations/root cause analysis. Work to complete documentation of deviations and events in appropriate systems
* Participate in shift exchanges, 1-1s, department meetings, attend meetings as necessary to facilitate area needs based on changes, etc.

How will you get here?

* Bachelors degree in microbiology, biology, and/or chemistry
* A minimum of 5 years within a GMP laboratory and/or QC laboratory
* Direct experience of three (3) years within testing laboratory in support of cell therapy manufacture, cell culture, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred.

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 cGMP practices, aseptic techniques, and analytical concepts
* Knowledge of industry standards such as ISO, ICH, FDA and USP preferred
* MS Office (Word, Excel, Power Point, etc.)
* Detail oriented - results driven
* Investigation and experience with Root Cause analysis, preferred
* Technical writing, preferred
* Able to work independently and as part of a team
* Ability to create, use and interpret scientific tables, charts, and graphs.
* Knowledge of testing and associated equipment protocols and requirements and analytical/microbiological testing instrumentation.
* Familiarity with Cell Therapy Testing methodology such as Flow Cytometry, ELISA testing, Gram Stain, etc.
* Strong interpersonal and communications skills; written and oral.
* Participate and provide input on timelines, potential compliance issues and other related QC activities.
* Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.
* Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
* 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.