Department: Quality Control
The Bioassay Lead is responsible for overseeing the daily activities related to the Bioassay Quality Control testing of Leukocyte Interleukin, Injection (LI) under current Good Manufacturing Practices (cGMP) for clinical application, analytical methods validation (AMV) and QC equipment/facilities operations and maintenance in support of Bioassay. Required to travel locally to other CEL-SCI facilities.
The Bioassay Lead works closely with the Bioassay Manager and Quality Control Manager. The Bioassay Lead reports to the Bioassay Manager.
A 4-year college degree (or higher education) in a relevant field Biochemistry, Biology, Cell Biology, or other related discipline.
At least five (5) years of experience with at least 1 year in a supervisory position of a QC laboratory in the Bioassay, Biopharmaceutical or Pharmaceutical industry working under GMP (rules). Specific experience should include: Bioassay testing, Cell Culture Maintenance, Radioactive material handling, raw materials testing, general laboratory supervision and maintenance (inventory control, equipment qualification, personnel training).
The Bioassay Lead must be a hands-on supervisor and be able to perform the following:
- Supervise assay performances
- Perform Bioassays
- Cell culture
- Adhere to written procedures
- Write scientific documents in a clear, logical manner
- Handle multiple and varied tasks
- File and maintain data records
- Operate and maintain various laboratory equipment
Duties also include:
- Oversee and participate in QC testing of clinical LI (Bioassay et al.)
- Participate in Raw Materials (RM) testing and release
- Participate in QC R&D and analytical methods validation (AMV) projects
- Participate in the stability testing program of clinical LI
- Manage inventory control
- Perform routine maintenance of the Bioassay lab
- Perform routine maintenance of QC equipment
- Training of staff and new personnel
- Any other task as assigned
Position is full time. Weekend, holiday, and evening work to be assigned on a rotating basis, as needed.
Limited local travel to other Company facilities may be required.
We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.
Please submit cv/resume to firstname.lastname@example.org. Reference the job title in the subject line of the email
CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.