Quality Control Supervisor, Gene Therapy
Today Lonza is a global leader in life sciences. 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.
Our state-of-the-art facility in the Houston area specializes in the production of cell and gene therapies. In the biopharmaceutical industry there is an increasing demand for development and manufacturing of these novel drugs. In response, we opened our 300,000-square-foot facility, fully dedicated to cell and gene therapy development and manufacturing, and the only site in our network where viral vectors are manufactured.
The Quality Control Supervisor, Gene Therapy role will be responsible for supervision of the Quality Control (QC) personnel performing in-process control, release, and stability testing of Viral Vector products. Works in cooperation with the QC tech transfer analysts and project leads to implement required test procedures and ensure adequate support to on-going manufacturing and stability campaigns.
- Responsible for direct supervision of the analysts performing in-process control, release, and stability testing of viral vector products. Acts as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems.
- Works collaboratively with the QC project leads and tech transfer analysts to ensure analysts are appropriately trained and able to support ongoing manufacturing and stability campaigns.
- Reviews testing and laboratory records for accuracy and compliance with cGMP and Lonza policies and principles.
- Works in collaboration with the QC scheduler to ensure testing is appropriately scheduled and resourced. Provides feedback to QC management and production planners when capacity constraints exist.
- 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.
- Bachelor’s Degree in Related Field.
- Advanced understanding of cell culture and molecular assays such as PCR and Infectious Titer
- Strong knowledge of cGMP requirements and previous experience with audits (customer and regulatory) required
- Experience with method qualification/validation and transfer desired
- Position is responsible for supporting the QC Viral Vector manager with cost center budget development, monitoring, and escalation of variances.
- Individual is expected to be competent and professional during all written and face-to-face interactions with internal and external customers. Will be called upon to represent group during audits for areas of expertise.
- Knowledge of SAP and TrackWise systems a plus.
- Demonstrated experience in management of complex tasks and projects.
- Able to communicate status, needs, forecasts, risks and timelines effectively to management.
- Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence
- Champions change speaking positively to and about others in all situations. Encourages a positive, solutions-focus attitude in all team members
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.