Quality Control Project Lead
Lonza
Summary
The Quality Control (QC) Project Lead will lead the introduction of new methods and processes into the Quality Control (QC) department through technology transfer, provide technical support for investigations, and act as the QC representative on project teams. This role supports method validation, ensures compliance with regulatory requirements, and contributes to the successful execution of QC testing for cell and gene therapy products.
Job description
What you will do
- Lead tech transfer activities including development of transfer plans, protocols, and reports.
- Provide QC representation in project team meetings and communicate project status and timelines.
- Review regulatory guidance and internal policies to ensure compliance with cGMP standards.
- Write, review, and approve test records, sampling plans, specifications, and QC documentation.
- Support stability programs and track testing progress and deliverables.
- Collaborate with cross-functional teams including QA, MSAT, and manufacturing.
- Assist with deviations, OOS investigations, CAPAs, and audit responses.
What we are looking for
- Experience from 3 to 5 years in Quality Control.
- Minimum of Bachelor's degree required in a scientific discipline.
- Experience with method validation/qualification and technology transfer in a QC environment.
- Knowledge of biological and cell-based assays such as flow cytometry, ELISA, HPLC, ddPCR, and qPCR is preferred.
- Familiarity with cell and gene therapy products preferred.
- Strong understanding of cGMP principles and regulatory compliance.
- Demonstrated ability to manage complex projects and prioritize tasks effectively.
- Strong communication skills, including writing technical procedures and presenting project updates.
- Proven ability to collaborate, lead teams, and build cross-functional relationships.
- Proficient in using spreadsheets, databases, and word processing software.
Requirements
- Experience from 3 to 5 years in Quality Control.
- Minimum of Bachelor's degree required in a scientific discipline.
- Experience with method validation/qualification and technology transfer in a QC environment.
- Knowledge of biological and cell-based assays such as flow cytometry, ELISA, HPLC, ddPCR, and qPCR is preferred.
- Familiarity with cell and gene therapy products preferred.
- Strong understanding of cGMP principles and regulatory compliance.
- Demonstrated ability to manage complex projects and prioritize tasks effectively.
- Strong communication skills, including writing technical procedures and presenting project updates.
- Proven ability to collaborate, lead teams, and build cross-functional relationships.
- Proficient in using spreadsheets, databases, and word processing software.
Benefits
- Performance-Related Bonus
- Medical, Dental & Vision
- 401(k) Matching
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- Employee Assistance Programs
- Paid Time Off
Company overview
Lonza is a pioneering global Contract Development and Manufacturing Organization (CDMO) and a world leader in pharmaceutical manufacturing services. Founded in 1897 in Switzerland, the company has evolved into the first and original CDMO, now operating as one of the largest Western CDMO networks with approximately 19,000 employees across more than 30 sites spanning five continents. Lonza specializes in transforming therapeutic discoveries into life-saving and life-enhancing treatments for patients worldwide. The company's comprehensive services span from early development to drug substance and drug product manufacturing, covering established and emerging technologies including mammalian biologics, small molecules, highly potent APIs, bioconjugates, mRNA, microbial products, and cell and gene therapies. With a focus on cutting-edge science, smart technology, and lean manufacturing, Lonza serves a diverse customer base ranging from emerging biotechs to global pharmaceutical companies, delivering integrated solutions throughout the entire treatment lifecycle.