Quality Control, Senior Technical Reviewer

Lonza • Portsmouth, NH

4d • Onsite

About The Position

The Quality Control (QC), Sr. Technical Reviewer will review analytical data, including A280, electrophoresis (SDS-PAGE, CE-SDS, icIEF), HPLC (GPC, IEX, peptide map), and bioassays (ELISAs, cell-based). Primarily office-based, this position requires occasional lab presence to perform assay observations, system owner activities, and lab maintenance to ensure continuous compliance and efficiency.

Requirements

• Bachelor's degree in a scientific field, with a preference for Biology, Microbiology or Biotechnology.
• 2-4 years' experience of protein stability and the analytical methods used to evaluate product stability.
• Good understanding of cGMP guidelines and how adherence to GMP impacts the way we work.
• Excellent organization, time management and prioritization skills.
• Able to make quality decisions based on the best available scientific data.
• Confident and resilient enough to thrive in a fast-paced environment.
• Willing to undertake a range of tasks for the effective running of the department.

Nice To Haves

• Advanced Graduate degree (M.S./Ph.D.) is preferred.

Responsibilities

• Perform technical review of batch release and environmental monitoring assays, as well as method transfer studies against standard operating procedures, protocols and GMP principles.
• Carry out work independently and make technical and quality decisions, including more complex decision making on the validity of assays in a safe and compliant manner.
• Plan and completes assigned tasks within the required timeframe communicating progress and escalate challenges to Line Manager and/or scientific lead as appropriate.
• Communicate with operators and supervisors to close-out technical review of assays and provides feedback for the recognition/development of analysts.
• Interpret data against study specifications, identifies atypical results/trends within data.
• Provide support for the progress of quality records as needed as well as be responsible for and lead investigations.
• Contribute to QC department general lab housekeeping, perform monitoring and maintenance of equipment and may take on system owner responsibilities.

Benefits

• Competitive salary and performance-based bonuses.
• 401(k) matching plan.
• Competitive compensation programs that reward high performance.
• Comprehensive medical, dental, and vision insurance.
• Access to our full list of global benefits: https://www.lonza.com/careers/benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior