Quality Control Manager- Analytical Method Validation

United States, Lexington (Massachusetts)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The QC Manager demonstrates expert understanding of executing method validation activities in a Quality Control Laboratory. This individual will determine method validation requirements, author and/or approve method transfer and validation plans, protocols and reports. Manages internal method timelines.

The QC Manager will oversee execution of internal as well as outsourced analytical testing and analytical qualifications of exosomes, biological molecules, oligonucleotides, small molecules, and drug products. This individual will assist in building and maintaining strong working relationships with technical counterparts internally and externally. Interprets data and resolves technical issues.

Key Responsibilities:

  • Manages internal timeline for Method Qualification/ Validation/ Verification in the Quality Control Laboratory.
  • Writes and develops method validation protocols, reports and test methods.
  • Oversees method validation protocol activities being performed in the laboratory.
  • Review of characterization data, including technical review of change control documentation and reports, deviations, OOS.
  • Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance resolving issues.
  • Resolve technical problems through scientific understanding, options assessment, and application of innovative solutions.
  • Generate complete, accurate, and concise laboratory documentation.
  • At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.
  • Responsible for identifying, alerting and proposing solutions to issues on instruments and or test executions; aids and implements recommended solutions and or corrective actions of OOT/OOS findings according to cGMP standards. 
  • Perform other duties as assigned
  • Level of this role is dependent on experience

Key Requirements:

  • Bachelor’s Degree or higher, preferred field in biochemistry, cell biology and/or microbiology or similar
  • 5+ years of experience preferred managing direct reports and demonstrated ability to mentor and coach employees
  • 8+ years of experience in analytical method development, analytical support of manufacturing campaigns, quality control, and method transfer.
  • Background in methodologies supporting both biologics and small molecules.
  • Ability to troubleshoot analytical instrumentation such as HPLCs/UPLCs. 
  • Preferred experience with DLS, NTA, ELISA, qPCR.
  • Has expert level Chromatography skills using Empower.
  • Direct experience in authoring and review of SOPs, assay qualification protocols and reports.
  • Strong knowledge of cGMP/ICH/FDA/EU regulations.
  • Work with minimal supervision, demonstrated ability to troubleshoot, quickly design and execute thoughtful experiments leading to innovative solutions.
  • Strong work ethic, strives to learn new things, and capable of working independently and in a collaborative environment.
  • Excellent communication, project management, and presentation skills (oral and written).

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R45954