Quality Control Project Lead

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.
• 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.
• 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.

About Lonza:

Qualifications

• Experience with method validation/qualification and technology transfer in a QC environment.

Preferred Qualifications

• Familiarity with cell and gene therapy products preferred.