Senior Quality Control Analyst I, Bioassay

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TheSenior QC Analystpositionwillexecute aninterdisciplinary set of testing( testing molecular biologytestingand bioassay testing)andlaboratoryoperations( management)to supportAAV-based gene therapymanufacturing operationson a incumbent willdemonstratestrengths in leadershipin the labwith a focus onsoundindependentthinking and a self-motivated mindsetto drive actions forward.

In addition the Senior QC AnalystIwill reviewenterand approveanalyticaldatagenerated internally andfrom external laboratories. Routine work includes release and stability testing critical reagent qualificationquality system ownership( investigationsdeviations CAPA change controls)method validation and transfer critical reagent qualification analyzedata and author technical documents.

The position is scheduled Wednesday Saturday as four 10 hour work days with flexibility to start between 7:00am 8:30am to support operational activities.

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

1. Performsroutine QC testingin a GMP environment to support product release and stabilityincluding butnot limited to;cell-based assaysquantitative PCR ELISA and microbiological test methods ( testing plate reading endotoxin testing total organic carbon testing conductivity testing media growth promotion).
2. Executes sample management in support of GMP manufacturing including but not limited to incoming sample receipt sample aliquoting sample transactions in LIMS sample distribution to testing laboratories and sample disposal.
3. Review and approval of cGMP analytical data for release and stability testing
4. Supports and leads QC Bioassay laboratory operations (ex. Instrumentqualification and maintenance. Passage cells qualify critical reagentsetc).
5. Author and support quality events; Change controls Deviation CAPA OOS Investigation as needed.
6. Support methodtransferand validation activities for development technical transfer and validation of late-stage assays for AAV-based gene therapy programs.
7. Author analytical method performance trend reports as needed.
8. Write prepare and present technical data technical reports and standard operating procedures (SOPs).
9. Model leadership behaviors and mentor/train junior staff
10. Workwith cross functional teamswith both internal and external stakeholders

1. BS in Cell Biology Molecular BiologyBiochemistryor a related discipline withminimum6-8years industry experienceor MS with 4-6 years experience.

1. 4Experiencein a GMP/GLP environment isa must.

1. Experience in routine mammalian cell culturerequired

1. Experience with quantitative PCR with cell-based potency assays isrequired. Experience performing immunoassays such as ELISAs strongly desired

1. Experience with statistical analysis (SoftMax JMP)andLIMS (LabVantage)preferred

1. Ability and desire to work in a fast-paced environment

1. Strong collaboration team-working skills and communication skills

1. Independently motivated and detail-oriented with good problem-solving ability

1. Strong communication interpersonal and organizational skills

Physical Demand Requirements

• Stand for extended periods of time with periodic stooping / bending / kneeling

• Able to lift push pull up to 50lbs.

• Climb ladders and stairs of various heights.

• Work in a lab environment requiring special protective clothing over the head face hands feet and body. This role requires the ability to wear personal protective equipment.
• Certain tasks may require use of a respirator; medical clearance will berequiredin advance.

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