Quality Control Sr. Manager, Gene Therapy
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.
This position will manage the Quality Control (QC) Gene Therapy asset within the Quality Control department. The assets includes the following:
- Gene Therapy (Viral Vector) laboratory - responsible for performing Cell Biology, Biochemistry, polymerase chain reaction (PCR), and Immunology assays in support of the production, release, distribution, and stability monitoring of Viral Vector products
- Raw Materials laboratory - responsible for sampling, testing, and management of outsourced tests in support of raw material release
- Project Leads – responsible for driving the introduction of new methods and processes into the Quality Control (QC) department via the technology transfer process, representation of the department on project teams, and providing technical support during investigations.
- Represents the Quality Control department in the Gene Therapy Asset Leadership Team
- Responsible for direct supervision of the Project Leads. Acts as an advisor/backup supervisor to the subordinate manager/supervisor for the Gene Therapy (Viral Vector) and Raw Material labs.
- Develops and maintains a tool for monitoring QC resource capacity. Provides feedback to QC management, program management, and production planners when capacity constraints exist.
- Collaborates with the Bio Analytical Services team, Manufacturing Science and Technology (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.
- Leads and mentors others with technical investigations.
- Prepares project plans, writes status reports, and gives oral presentations to customers and management.
- Provides technical review of Statements of Work (SOWs) to support contract manufacturing activities.
- 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.
- Bachelor of Science in a related field, Master’s or PHD is preferred.
- Extensive experience in Quality Control function with a biologics firm.
- Advanced leadership skills and expertise in managing diverse teams.
- Must be able to comply and adhere to Good Manufacturing Practices (cGMP) principles.
- Knowledge of PCR, cell/viral-based assays (potency, infectious titer), and requirements for raw material testing required.
- Experience with method validation and technology transfer required.
- Knowledge of SAP, LIMS, and TrackWise systems a plus.
- Uses experience and knowledge to solve problems, make decisions or make plans for their area. Makes recommendations for site and other departments on site. Erroneous decisions or failure to achieve goals will result in critical delays in schedules or unit operations and may jeopardize overall business activities.
- Develops goals and objectives for team to maintain focus and meet department goals. Develops and monitors performance measures to understand effectiveness, efficiency, and quality of the group. Routinely assesses resource utilization.
- Is able to express information to individuals or groups taking into account the audience and nature of the information (i.e. explain technical concepts to non-technical audiences). Presents ideas in a persuasive manner. Communicates frequently with members of other departments and customers.
- Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence.
- Ensures delivery excellence for own goals and those of his/her team. Overcomes roadblocks to task/project completion through creative/strategic thinking while maintaining quality standards.
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.