Senior Quality Control Analyst I, Bioassay

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

The Senior QC Analyst position will execute an interdisciplinary set of testing (e.g. microbiology testing, molecular biology testing and bioassay testing) and laboratory operations (e.g. sample management) to support AAV-based gene therapy manufacturing operations on a shift. The incumbent will demonstrate strengths in leadership in the lab with a focus on sound independent thinking and a self-motivated mindset to drive actions forward. 

In addition, the Senior QC Analyst I will review, enter and approve analytical data generated internally and from external laboratories. Routine work includes release and stability testing, critical reagent qualification, quality system ownership (e.g. OOS investigations, deviations, CAPA, change controls), method validation and transfer, critical reagent qualification, analyze data, and author technical documents. 

Work Model:

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

Responsibilities:

1. Performs routine QC testing in a GMP environment to support product release and stability including but not limited to; cell-based assays, quantitative PCR, ELISA, and microbiological test methods (e.g. bioburden 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. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc). 
5. Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed. 
6. Support method transfer and 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. Work with cross functional teams with both internal and external stakeholders 

Requirements:

1. BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 6-8+ years industry experience or MS with 4-6 years’ experience. 

1. 4+ Experience in a GMP/GLP environment is a must. 

1. Experience in routine mammalian cell culture required 

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

1. Experience with statistical analysis (SoftMax, JMP) and LIMS (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 be required in advance. 

#LI-AJ1 #LI-Onsite