Quality Control Supervisor

Summary:

The Quality Control Supervisor will be part of the Angiocrine QC team that supports all QC laboratory activities in support of release testing of a cell-based therapy undergoing clinical investigation. A successful candidate should have some experience in cell/gene-therapy product testing under GMP, including familiarity with aseptic technique, immunoassays, flow cytometry, and PCR. This is a full-time position and will report to the Director of Quality.

Position Responsibilities and Requirements:

• Working with cells and products of animal or human origin
• Working with replication-incompetent retrovirus
• Working with chemicals or potential hazard
• Knowledge of current good manufacturing practices (cGMP) as they apply to Quality Control
• Supervise daily activities to maintain QC laboratory in a GMP-compliant state, including
  • Keeping current on required training documents
  • Following standard operating procedures (SOPs), protocols, and other instructions from management
  • Ensuring that equipment/instrument maintenance, calibration, and cleaning is properly documented
  • Ensuring segregation of GMP-related materials and test samples
  • Performing release testing for incoming raw materials
  • Maintaining cleanliness and organization of laboratory environment
• Oversee GMP bioanalytical release testing for cell banks and/or finished cell-based drug products
• Oversee GMP stability testing for materials, cell banks, and/or finished drug products
• Conduct out-of-specification (OOS) investigations and deviations
• Conduct peer review of data generated in QC lab
• Oversee inventory of laboratory consumables
• Oversee the validation of bioanalytical test methods
• Oversee the qualification of equipment/instruments
• Oversee data trending and other quality metrics
• Manage QC personnel against performance objectives

Some weekend work may be required depending on testing schedules.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Preferred Education and Experience:

• Related Bachelor’s degree (e.g. biology, biotechnology, biochemistry)
• 5+ years work-related experience in cGMP QC laboratory setting
• Working familiarity with software such as Microsoft Word, Excel, and PowerPoint
• Working experience with adherent cells
• Bioanalytical skills with hands-on knowledge/experience in immunoassay/ELISA, flow cytometry, PCR, and/or other bio-analytical techniques.
• Effective and clear written and verbal communication
• Ability to work in a high paced team environment.

Additional Information:

This position is based in San Diego, CA.

Angiocrine is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.