Associate Director QC Analytical and Cell Based Assay

COMPANY:

Start-up AAV gene therapy and engineering company

LOCATION:

Greater Los Angeles, CA area

TITLE:

Senior Manager/Associate Director QC Analytical and Cell-Based Assay (title will be dependent on experience)

TYPE:

Direct-hire, full-time

RELOCATION ASSISTANCE:

Yes

ROLE RESPONSIBILITIES:

The Sr. Manager/AD will be responsible for managing analytical, stability and the reference standard QC operations, including ddPCR and cell-based assay. Other responsibilities include:

• Short term responsibilities will include lab start up activities and include assay qualification and execution at the bench. The need for hands on execution of analytical methods will decrease over time as the lab grows.
• Manage the QC Analytical team
• Oversee operations of the internal QC Analytical supporting manufacturing, release, stability, and vector product testing.
• Oversee external lab operations to ensure adherence to quality agreement and GMP requirements
• Collaborate with analytical development and provide SME guidance for method transfer, qualification and validation activities for ddPCR, qPCR, ELISA, HPLC and cell-based assays.

CANDIDATE REQUIREMENTS:

• Bachelor's degree with 10+ years of Quality and/or Regulatory experience
• Experience running a QC lab or analytical group
• Strong people management/leadership skills
• Specific hands-on experience with qualification and execution of analytical methods common to gene therapy operations with specific interest in cell-based assays.

If you meet the requirements above and would like to be considered for this position, apply on-line now to be contacted with further details. This is not a fully remote role.