Quality Control Analyst II – Bioassay

Summary:

This position reports to the Associate Director, Quality Control Bioassay. The QC Analyst II, Bioassay will perform cell-based testing (e.g. mRNA expression and Potency assays) to support: in-process, drug substance and drug product release, stability to support AAV-based gene therapy programs. They will work cross-functionally with team members within Quality Control and internal stakeholders across Analytical Development and Quality Assurance. Routine work includes release and stability testing, critical reagent qualification, method validation and transfer, critical reagent qualification, analyzing data, and authoring technical documents.

Responsibilities:

1.   Perform routine QC testing including, but not limited to, quantitative PCR and cell-based assays in a GMP environment to support product release and stability.

2.   Review and approve of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platforms for both internally and externally generated data.

3.   Support QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc).

4.   Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.

5.   Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs.

6.   Author analytical method performance trend reports, as needed.

7.   Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).

8.   Work with cross functional teams with both internal and external stakeholders

Requirements:

1.     BS or MS in Biochemistry, Biology, Chemistry or a related discipline with 2+ years (BS/MS) relevant industry experience

2.     Experience in a GMP/GLP environment is a must.

3.     Experience in routine mammalian cell culture required

4.     Experience with quantitative PCR required.  Experience with cell-based potency assays is required. Experience performing immunoassays such as ELISAs strongly desired

5.     Experience with statistical analysis software (SoftMax, JMP) preferred

6.     Strong collaboration and team-working skills

7.     Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines

8.     Should be highly motivated, demonstrate strong technical leadership skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities