Quality Control Lead, Cell Therapy
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.
The QC Lead will assist Quality Control Management with leading and scheduling work for the QC Cell Therapy, Cell Biology team responsible for performing the product specific testing of in-process, release, and stability Cell Therapy product samples. Assists with execution of more complex test methods and routine testing as needed.
- Performs Quality Control (QC) biological/cell based testing of Cell Therapy in-process, release, and stability samples. Typical test methods performed include Cell Counts (automated and manual), Cell Proliferation, ELISA, and Hematology based methods.
- Assists with scheduling of work for fellow team members ensuring adequate resources are available to support production schedules.
- Write original and revise current SOPs, Forms and Test Records.
- Writes edits and approves Lab Investigations, Deviations, and CAPAs as required.
- Responsible for initiating Change Controls and completing necessary documentation in support of new equipment setup or process changes.
- Actively participates in support of Cell Therapy technology transfer activities and validation of analytical methods including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation protocols.
- Reviews testing and laboratory records for accuracy and compliance with cGMP and Lonza policies and principles.
- Performs other duties as assigned.
- Bachelor degree in scientific studies
- Experienced knowledge of quality control
- Experience with Cell Biology techniques including cell counting, ELISA, cell proliferation, and hematology methods is desired
- Previous experience writing and leading deviations and lab investigations required.
- Able to develop and deliver training programs for specialized and advanced activities. Trains trainers on how to develop effective on the job training.
- Aids in development of training plans and identification of training gaps.
- Proficient in the use of spreadsheets, databases, and word processing software
- Knowledge of SAP and TrackWise systems a plus.
- Uses experience and knowledge to solve problems, make decisions, and develop plans for the group. Makes recommendations for the department.
- Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
- Improves efficiency of self and team by clearly defining and analyzing problems and implementing new ways of approaching work.
- Demonstrated experience in management of complex tasks and projects.
- Skilled at establishing clear and understandable directions and goals. Escalates roadblocks to project/task completion.
- Able to prioritize own work and aid in setting group priorities.
- Strong organizational skills.
- Able to write complex procedures and reports.
- Able to communicate status, needs, forecasts, risks and timelines effectively to management.
- Communicates expectations effectively to members on project teams and in area.
- Uses mediation skills to resolve or avoid conflict.
- Capable of leading teams and identifying appropriate path to meet team objectives.
- In conjunction with program management team, helps develop loyalty and trust with customers. Able to make and deliver on promises of projects within group control.
- Actively works to establish strong relationships within the group and with other department managers to improve harmonization and effectiveness.
- 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 complete both routine work assignments and projects on time or ahead of schedule without routine reminders.
- Leads by example – models good behavior, work ethic, and teamwork.
- Champions change, speaking positively to and about others in all situations. Is optimistic and displays a positive attitude even during periods of adversity
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.