QC Supervisor- Technical Transfers
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.
Lonza in Portsmouth, NH is searching for a QC Technical Services Supervisor to join our growing QC team. As our QC Technical Services Supervisor, you will oversee a team of Analysts and Specialists who are responsible for support of Biochemistry and Raw Material technical transfers into the Lonza Manufacturing facility. You will have oversight of Specialists to ensure right first time creation of raw material documentation and creation of portions of Product Quality Reports. You will also have oversight of Analysts who will provide excellent technical execution of analytical methods in support of technical transfers and validations. The ideal candidate will have a history in Leadership and experience in a laboratory setting (Biochemistry and/or Raw Materials highly preferred).
- 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.
- Basic understanding of regulatory requirements and Lonza policies pertaining to Validation of Analytical methods and Raw Materials in a Quality Control environment. 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 training of Analysts on analytical methods (execution and review training), provide support for investigations, PQR’s and other quality records.
- Manage the creation, review and approval lifecycles of Raw Material specifications, monographs and other documentation as appropriate with Specialists.
- Develop the technical and GMP skills of QC Analysts and QC Specialists and perform mid-year and annual reviews of supervised QC personnel.
- Identify and develop plans for efficiency to technical transfer requirements (creation of documentation, execution, review and approval cycles).
- Have a keen attention to detail and be able to manage multiple projects for self and team. Create a management tool for Raw Material documentation creation.
- Act as liaison for team at internal and external Customer and Team meetings.
- Be able to work and negotiate with cross functional teams (QA, MSAT).
- Comfort working with and negotiating timelines with senior management, senior scientists and peer leaders.
- Bachelor degree. Preferred area of study in Biology, Biochemistry or Related Science Fields.
- Experience with supervising a team with the ability to motivate a team of broad skills.
- Experience with using project-planning tools such as Microsoft Project.
- Experience/understanding of analytical method validations and transfers across multiple specialties, including instrument validation and implementation.
- Experience/understanding of Raw Material validations/transfers/implementation in a laboratory setting.
- Investigation and deviation writing in Trackwise or similar system.
- Knowledge in use of laboratory software systems such as LIMS, Trackwise, etc.
- 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.