Quality Analyst II, Quality Control Molecular Biology - Woburn, MA Woburn, Massachusetts

Orbis Clinical is seeking an Analyst II, Quality Control Molecular Biology located in Woburn, MA for up until the end of the year.

Job Title: Analyst II, Quality Control Molecular Biology

Location: Woburn, MA

Contract: Up until the end of the year

Summary

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.
• 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. 
• 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  

Lab:

• 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.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $51.72 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.