Quality Control (QC) Project Lead, Gene 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 purpose of the Quality Control Project Lead role is to support the Quality Control (QC) department via the technology transfer process, represents the department on project teams, and provides technical support during investigations.
- Participates in the initial assessment of new products and processes.
- Provides input to program management regarding QC capabilities and requirements for method qualification/validation. Reviews applicable regulatory guidance and internal policy documents to ensure compliance.
- Provides technical review of Statements of Work (SOWs) to support contract manufacturing activities.
- Provides QC representation to project team meetings. Responsible for relaying pertinent information such as production schedules and information requests to applicable QC groups.
- Writes, reviews, and/or approves Test Records/Forms, Sampling Plans, and Specifications.
- Leads tech transfer activities related to QC including generation of a QC master transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines
- Works in cooperation with BioAnalytical Services to design qualification, and validation protocols.
- Performs QC assessment of new raw materials required to support GMP manufacturing and testing.
- Assists with responses to audits, deviations, out of specification (OOS) investigations, and corrective/preventative actions (CAPA).
- Bachelor Degree in Life Sciences, preferably in Microbiology/Biology.
- Experience with method validation and technology transfer required.
- Knowledge of biological cell based assays such as proliferation/cell count and viability, flow cytometry, ELISA, and PCR preferred.
- Prior experience working with cell or gene therapy products a plus.
- Able to develop and deliver training programs for specialized and advanced activities. Trains trainers on how to develop effective on the job training.
- Knowledge of Good Manufacturing Processes (cGMP).
- Knowledge of SAP and TrackWise systems a plus
- Skilled at establishing clear and understandable directions and goals. Escalates roadblocks to project/task completion.
- Able to communicate status, needs, forecasts, risks and timelines effectively to management
- 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.
- Champions change speaking positively to and about others in all situations.
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.