Position Title: QC Associate, Microbiologist
Position Level: Century Professional Level
Reports to: Associate Director, QC Microbiology
Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of current cell therapies. Century's genetically engineered, universal iPSC-derived immune effector cell products are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care.
Century's foundational technology is built on induced pluripotent stem cells (iPSCs) that have unlimited self-renewing capacity. This enables complex cellular engineering to produce controlled cell banks of modified cells that can be expanded and differentiated into desired immune effector cells, which can supply vast amounts of allogeneic, homogeneous therapeutic products. This platform differentiates Century from other approaches that utilize non-renewable donor-derived cells.
The QC Associate Microbiologist is responsible for microbiology testing in support of Century's genetically engineered cell therapy products clinical manufacturing. This role will interact extensively with other Quality Control and analytical development team members and will be expected to support routine testing, training, assay transfer and validation. The successful candidate will need strong scientific background, interpersonal skills, and ability to work collaboratively with other groups across organizations.
This role is based in Branchburg, NJ (TBDB18)
* Perform microbiological testing in support of in-process and release testing for genetically engineered cell therapy products, using rapid microbial methods for microbial identification, endotoxin and sterility testing and growth promotion testing of media.
* Perform environmental monitoring inside ISO 5 (BSC's) and cleanrooms, aseptic gowning, and aseptic process simulations (APS).
* May support analytical testing with flow cytometry and PCR testing.
* Maintain, calibrate, and operate microbiology equipment.
* Maintain laboratory material and reagent inventory.
* Analyze environmental monitoring data and complete routine trend reports.
* Assist in laboratory and product failure investigations.
* Document testing in accordance with cGMP requirements.
* Author technical and scientific documents including protocols, reports, and SOPs.
* Support tech transfer of methods to manufacturing for internal and external QC testing.
* Participate in assay validation activities.
* Foster a collaborative and scientifically rigorous team culture.
* B.S. or M.S. in Microbiology, Cell Biology, Molecular Biology, Biotechnology, Biological Sciences or related discipline.
* Minimum 4 years of experience working in a cGMP microbiology laboratory setting.
* Experience with environmental monitoring, aseptic technique, growth promotion testing, microbial identification, and US/EU compendial methods.
* Experience working in support of cell therapy products is preferred.
* Experience with flow cytometry, PCR, and molecular techniques is a plus.
* Excellent oral and written communication skills.
Century Therapeutics Inc. is an Equal Employment Opportunity/Affirmative Action Employer - Minority/Female/Disability/Veteran. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status or any other characteristic protected by federal, state, or local law.