Manager of Bioassay

Posted 5 months ago

Manager of Bioassay

Department:  Quality Control

The Manager of Bioassay is responsible for overseeing the day-to-day activities related to the Bioassay quality control testing of Leukocyte Interleukin, Injection (LI) under current Good Manufacturing Practices (cGMP) for clinical application, assay development, 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 Manager of Bioassay works closely with and reports to the Director of Quality Control.


A 4-year college degree (or higher education) in a relevant field Biochemistry, Biology, Cell Biology, or other related discipline.


At least ten (10) years of experience with at least 5 years in a supervisory position of a QC laboratory in the Bioassay, Biopharmaceutical or Pharmaceutical industry working with under GMP (rules). Specific experience should include: Bioassay testing, ELISA experience, Cell Culture Maintenance, Radioactive material handling, raw materials testing, general laboratory supervision and maintenance (inventory control, equipment qualification, personnel training). Assay development experience


The Manager of Bioassay must be hands-on and be able to perform the following:

  1. Supervise technicians
  2. Perform Bioassays
  3. Cell culture
  4. Perform ELISAs
  5. Adhere to written procedures
  6. Write scientific documents in a clear, logical manner
  7. Handle multiple and varied tasks
  8. File and maintain data records
  9. Operate and maintain various laboratory equipment

Duties also include:

  1. Oversee and participate in QC testing of clinical LI (Bioassay et al.)
  2. Participate in Raw Materials (RM) testing and release
  3. Participate in QC R&D and analytical methods validation (AMV) projects
  4. Participate in the stability testing program of clinical LI
  5. Manage/Supervise Inventory control
  6. Oversee routine maintenance of the Bioassay lab
  7. Manage routine maintenance of QC equipment
  8. Training of staff and new personnel
  9. Documentation
  10. 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.


Baltimore, MD

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.

Please submit cv/resume and cover letter to  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.

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