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Lonza Portsmouth, United StatesToday, 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 exc ...
Quality Control Manager, Cell Therapy - Portsmouth, United States - Lonza
Description
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 is building a large scale dedicated facility to allogenic product for a key customer. This position is responsible for management of the large scale allogenic manufacturing Quality Control (QC) laboratory.
This laboratory is expected to perform Cell Biology, Biochemistry, and Safety assays in support of the production, release, and distribution of Cell Therapy products.
During the construction phase of QC labs, the QC Manager is expected to work in close collaboration with Global Engineering team to develop QC lab design, instrument requirements and develop associated workflows.
The QC Manager works in close cooperation with the Technical Services and Bio Analytical Services groups to ensure client methods are adequately qualified/validated and successfully transferred into the QC lab for use in support of the Operations.
Key Responsibilities:
Responsible for supervision of the Cell Therapy lab. Acts as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems. Reviews testing and laboratory records for accuracy and compliance with cGMP and Lonza policies and principles.
Develops and maintains a tool for monitoring QC resource capacity. Provides feedback to QC management and production planners when capacity constraints exist.
Collaborates with QC Technical Services group, Bio Analytical Services team, MSAT, and program management to drive technical transfer, staff training, and assay qualification/validation activities.
Leads, mentors, and coaches staff through routine one-on-one meetings, team meetings, and effective performance management. Sets and delivers on individual and team goals that support the department and site strategy. Takes personal accountability for both his/her own and the team's actions. Writes, reviews, and/or approves SOPs, sampling plans, protocols, and specifications. Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA). Actively works to ensure responses are completed on-time. Escalates roadblocks to completion and provides potential solutions. Prepares monthly management reports including budget analysis and project updates. Actively monitors spending for area. Predicts and escalates potential spending variances. Identifies corrective actions for spending variances. Develops and monitors team performance measures to understand effectiveness, efficiency, and quality of group performance.Key Requirements:
Bachelor's degree in sciences required
Preferred area of study:
Life SciencesMinimum 8 years of experience working in a biotechnology environment. Familiarity with Pharmaceutical Industry related to cGMP, regulatory standards and Biotech processes desirable.
Minimum 5 years of experience in people management or similar tack record of managing projects in another role. Demonstrated ability to handle large and complex projects. Experience working in QC required.
GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred.
Demonstrated knowledge in biological, cell based assays including flow cytometry and PCR.Experience with method validation and technology transfer.Proficient in the use of spreadsheets, databases, and word processing software.
Ability to perform statistical analysis of data.
Knowledge of LIMS, SAP and TrackWise systems a plus.
Experience with implementation of new QC Equipment preferred. Exposure to Six Sigma methodologies and concepts, including process improvements / efficiency projects a plus.
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.
