Analyst II, Quality Control Molecular Biology

About the role

This position is in the Gene Therapy Quality Control Molecular Biology group. The QC Analyst II will perform analytical methods including but not limited to GC titer determination by ddPCR and qPCR, impurity testing, and other methods as needed to support in-process, drug substance, and drug product release, stability, and 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.

Responsibilities

• Performs routine QC testing including but not limited to: ddPCR, dPCR, and qPCR test methods in support of in-process, release, and stability.
• Review and approval of cGMP analytical data for release and stability testing from internal and external analytical test methods.
• Supports QC Molecular Biology laboratory operations (e.g., instrument qualification and maintenance, housekeeping, qualify critical reagents).
• Author and support quality events: Change controls, Deviation, CAPA, OOS Investigation, as needed.
• Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/validation protocols, and Method transfer/validation reports for internal and external methods.
• Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs.
• Author analytical method performance trend reports, as needed.
• Work with cross-functional teams with both internal and external stakeholders.

Requirements

• Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must.
• BS or MS in Biochemistry, Biology, Chemistry, or a related discipline with 2+ years (BS/MS) relevant industry experience.
• Hands-on experience with performing dPCR, ddPCR, and/or qPCR test method execution required.
• Strong collaboration and team-working skills.
• Strong communication, interpersonal, and organizational skills.
• Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Highly motivated, with good technical skills, excellent organizational and communication skills, and the ability to multitask in a fast-paced environment with changing priorities.

Lab Physical Demand Requirements

• Stand for extended periods of time with periodic stooping, bending, or kneeling.
• Able to lift, push, pull up to 50 lbs.
• 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 the use of a respirator; medical clearance will be required in advance.

Pay

Target PR range: $39–$49/hour, DOE.