QC Technical Services Manager
United States, Portsmouth (New Hampshire)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
Lonza in Portsmouth, NH is searching for a QC Technical Services Manager to join our growing QC team. As our QC Technical Services Manager, you will oversee a team of Scientists who are responsible for technical transfer of QC analytical methods into the Lonza Manufacturing facility. This role requires exceptional project management skills in software such as Microsoft Project or similar software packages. The ideal candidate will have a successful background and understanding of technical transfer of analytical methods in the QC biotechnology environment.
- Hiring, organizing, training and retaining energized, motivated, team oriented staff. Will need to stress and carry forward operator training, education and advancement. Identifies QC responsibilities, work to be performed and timelines pertaining to area of responsibility.
- Understand regulatory requirements and Lonza policies pertaining to Validation of Analytical methods in a Quality Control environment. Ensure Quality Control policies or procedures are appropriate and establish and/or revise, as necessary. Ensure regulatory and customer inspection readiness and represent the department and participate in audits as required.
- Manage short and long term projects for team regarding analytical transfer, investigations, PQR’s and other quality records.
- Develop the technical, GMP and leadership skills of QC Scientists and perform mid-year and annual reviews of supervised QC personnel.
- Able to author and review validation protocols and reports. Able to understand and review data for analytical validations as necessary to assist team with meeting timelines. Author and review memos as needed.
- Identify and develop plans for efficiency to technical transfer requirements (protocol, execution, report).
- Act as liaison for team at internal and external Customer and Team meetings.
- Bachelor or Advanced preferred (MS/PhD). Preferred area of study in Biology, Biochemistry or Related Science Fields.
- Significant experience with supervising a team with the ability to motivate a team of broad skills.
- Significant experience with in using project-planning tools such as Microsoft Project.
- Significant experience with analytical method validations and transfers across multiple specialties, including instrument validation. and implementation
- Investigation and deviation writing in Trackwise or similar system.
- Knowledge in use of the LIMS, Empower, Softmax and other lab software systems in support of technical transfers.
- Ability to plan 6-12 months in advance for project and resource planning.
- Potential history of implementing innovation within a team.
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.