Analyst II, Quality Control Molecular Biology

The Steely Group; Woburn (MA); On-site; USD 75,000 - 105,000; Full time

Job summary

The Steely Group is seeking a QC Analyst II for its Gene Therapy Quality Control Molecular Biology group. The role involves performing analytical methods such as ddPCR, dPCR, and qPCR to support in-process, release, and stability testing for AAV-based programs.

You will collaborate with Quality Control, Analytical Development, and QA teams to ensure compliance and timely data delivery. Responsibilities include data review of cGMP analyses, instrument qualification support, SOP and method

Qualifications

• Experience in a cGMP QC lab is required.
• BS or MS in Biochemistry, Biology, Chemistry or related discipline with 2+ years of experience.
• Hands-on ddPCR, dPCR and/or qPCR method execution.

Responsibilities

• Performs routine QC testing including ddPCR, dPCR, and qPCR for in-process, release, and stability.
• Review and approve cGMP analytical data for release and stability testing from internal and external methods.
• Supports QC Molecular Biology lab operations (instrument qualification, maintenance, housekeeping, reagents qualification).
• Author and support quality events; change controls, deviations, CAPA, OOS investigations as needed.
• Write, prepare, and present technical data, reports, SOPs, and transfer/validation documents.
• Support method transfer and validation activities for late-stage assays in AAV-based gene therapy programs.
• Author analytical method performance trend reports as needed.

Skills

cGMP QC lab

ddPCR

dPCR

qPCR

team collaboration

communication

Education

BS/MS in Biochemistry/ Biology/ Chemistry

Tools

ddPCR

dPCR

qPCR

Job description

This position is in the Gene Therapy Quality Control Molecular Biology group.

The QC Analyst II will perform analytical methods including but not limited 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 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

• 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 interna and external analytical test methods
• Supports QC Molecular Biology laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc).
• 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 protocol, Method transfer/ validation report 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.

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

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