Lonza

Quality Control, Senior Technical Reviewer

Job ID: R75381
Location
Portsmouth, NH
Hours/week
40 hrs/week
Payrate range
Unknown

Quality Control, Senior Technical Reviewer

Location: On-site, Portsmouth, NH.

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.

What you will get:

  • An agile career and dynamic working culture.

  • An inclusive and ethical workplace.

  • 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 you will do:

  • 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.

What we are looking for:

  • Bachelor's degree in a scientific field, with a preference for Biology, Microbiology or Biotechnology. Advanced Graduate degree (M.S./Ph.D.) is preferred.

  • Good understanding 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.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

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