Posted in Science 30+ days ago.
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Location: Portsmouth, New Hampshire
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
We strive to be the leading supplier using science and technology to improve the quality of life.
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Act as a senior team member of the Quality Control department to support technology transfer, validation, deviation support, and investigation projects. Subject Matter Expert for all applicable disciplines. Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles, and may impact future concepts, products, or technologies. Supports the review of all regulatory documents including APRs and BLAs. Direct contact with customers and project teams. Acts as advisor to leadership staff to meet schedules and/or resolve technical problems. Troubleshoot assay and instrumentation issues involving data mining, trending and analysis to identify problems. Provides hands-on and theoretical training as appropriate for QC and other operational groups. Recognized by site and industry as a technical leader. Maintains current with industry practice and trends through seminars, research, bench-marking.
- Acts as adviser to leadership staff to meet schedules and/or resolve technical problems
- Represent QC and Lonza in customer meetings to receive/deliver information, request and requirements.
- Document review for transfers/validations/Deviations/Investigations
- Measures throughput, performance and other appropriate metrics and report them to management.
- Maintains an awareness of site safety objective and ensures these are communicated and adhered to in the QC department.
- Develop the technical, GMP and leadership skills of QC personnel and perform mid-year and annual reviews of supervised QC personnel (if relevant).
- Demonstrated leadership of either direct reports or indirect reports through a Project Team. Must have experience in resolving conflict within a project team and
be able to influence to redirect the team as required.
-Long term, the position may have direct reports of junior staff within the department-
Bachelor's degree in Biochemistry, Chemistry, Engineering, or relevant scientific specialty. Master's or Doctorate degree preferred.
Extensive experience in a GMP environment
Experience in Validations, Qualifications and Transfers of analytical methods to a QC environment
Excellent troubleshooting skills and ability to successfully train junior staff
Encourage a positive team working environment where peers and team members feel encouraged to learn from this candidate
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.