Manager, Quality Control - Cell Therapy (2nd Shift)
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 Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity the Cell Therapy. The QC Lab Manager will be responsible for management of the Quality Control (QC) Cell Therapy laboratory second and third shift personnel responsible for performing Cell Biology, Biochemistry, and Safety assays in support of the production, release, and distribution of Cell Therapy products. Works in 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 Cell Therapy Operations.
Shift hours are Monday through Friday 2pm to 11pm. Please ensure you are able to work these hours before submitting an application
• Responsible for supervision of the Cell Therapy second and third shift team. 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.
• Partners with QC Cell Therapy Manager, Supervisor and Leads to ensure adequate coverage for in-process testing occurring on second and third shift.
• Develops and maintains a tool for monitoring QC resource capacity. Provides feedback to QC management and production planners when capacity constraints exist. Testing includes manual and automated cell counts, hematology analysis, and flow cytometry.
• 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.
• 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 degree in related Science field of study
• Mater degree preferred
• Responsible for cost center budget development, monitoring, and escalation of variances
• Working knowledge of LIMS, SAP and TrackWise a plus
• Demonstrated knowledge in biological, cell based assays including flow cytometry and PCR.
• Experience with method validation and technology transfer preferred.
• Stays aware of new technologies and potential applications in area.
• Develops training plans and performs identification and remediation of training gaps.
• Proficient in the use of spreadsheets, databases, and word processing software.
• Uses experience and knowledge to solve problems, make decisions or make plans for their area. Makes recommendations for department.
• Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
• Demonstrated experience in management of complex tasks and projects.
• 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).
• Actively works to establish strong working relationships within the group, between groups, and with other department managers to improve harmonization and effectiveness.
• Capable of leading teams and identifying appropriate path to meet team objectives.
• Helps develop loyalty and trust with customers. Able to make and deliver on promises of projects within group control.
• Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence.
• Demonstrated leadership skills as well as team building and mentoring skills.
• Can be counted on to ensure his/her own and team's routine work assignments and projects are completed on time or ahead of time without routine reminders.
• 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.