Shenandoah Biotechnology, Inc., a FUJIFILM Irvine Scientific company, is a leading manufacturer of recombinant proteins. Our vision is to provide a superior and affordable source of recombinant proteins to the academic and industrial scientific research communities. Our team are a passionate group from diverse backgrounds. Our headquarters and state-of-the-art, manufacturing facility is located in Warminster, Pennsylvania. Founded in April 2006, we joined Fujifilm Group in March 2022 and are rapidly expanding our operations.
We are hiring a Quality Control Supervisor. The Quality Control Supervisor will execute and supervise daily QC operations and testing of recombinant proteins for in process and final product release assays.
Provide work direction to and supervision of the QC staff
Microbiology and/or biochemical assay qualification and routine testing
Environmental monitoring of utilities and classified rooms/spaces to support new utility and facility qualifications
Author and review technical documents, method transfer/qualification reports, standard operating procedures, change controls, and investigations for the performance of laboratory methods
Trouble-shoot analytical process and equipment issues
Monitor and maintain QC Laboratory equipment and process validation status.
Planning and test method execution to meet established delivery timelines
Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning
Training of laboratory personnel in methods and procedures
Review of laboratory generated data and results
Sterility Assurance Specialist, Microbiology will provide technical expertise and guidance for all activities associated with Microbiology, Sterilization, and Aseptic programs to support Manufacturing,
Technical and practical understanding of the following analytical methodologies: electrophoretic (CE-SDS, SDS-PAGE, ie IEF), impurity (host cell protein ELISA, residual Host Cell Protein ELISA, etc.) and compendial (pH, osmolality, bioburden, endotoxin, sterility) assays.
BA/BS or Master’s degree in Biology, Molecular Biology, Cell Biology, Chemistry, or Biochemistry.
If Bachelor Degree - 3-4 years of experience along with GMP experience
If Master’s Degree - 2-3 years of relevant experience along with GMP experience
At least 1 year of supervisory experience
Experience with analyzing samples using RT-PCR, BacT, and other testing methods
Attention to detail and strong organizational skills
Ability to multi-task, maintain a positive attitude/work environment
Knowledge of working in a GLP, cGMP environment
Knowledge of laboratory operations
General knowledge of computer systems and productivity software
Ability to speak, write and read English fluently.
Shenandoah Biotechnology, Inc., a FUJIFILM Irvine Scientific company is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.