Experis, a ManpowerGroup company has an exciting contract opportunity for one of our key clients, a Fortune 500 American global biopharmaceutical company that is engaged in the discovery, development, and manufacturer of healthcare products.
Project Details: FULL TIME
QC Analytical Technical Lead
Gaithersburg MD 20878 United States
- Represent QC Analytical as a technical SME in cross-department and cross-site teams.
- Support design and execution of QC Stability studies for multiple products.
- Support design of in-process control and release testing strategy for multiple cell therapy products.
- Design and execute technical studies to support current/proposed lab operations and continuous improvement.
- QC Lead in drafting and supporting risk assessments for multiple cell therapy products.
- Lead the technical training function for the QC Analytical team, including designing on-the job performance training (OJT), scheduling, execution, and continuous improvement.
- Perform a variety of analytical assays, including molecular and cell-based assays.
- Author, revise and review SOPs, equipment validation, method qualification, technical study protocols/reports, and risk assessments.
What you have to offer.
- Minimum requirements; Bachelor's Degree in sciences with 6 plus years of experience in a QC Analytical GMP lab setting
- Experience with safe lab practices and the handling of biological material.
- Strong attention to detail and the ability to work cross-functionally.
- Excellent communication and organizational skills.
- Ability to participate in regulatory inspections and convey appropriate technical information clearly and concisely.
- Ability to exercise sound judgement and decision making to ensure compliance with regulations under aggressive timelines.
- Experience with Flow cytometry, ELISA, PCR, molecular and cell-based assays, and other applicable methods. Proven record in leading strategy and execution of QC method qualification and method tech transfer.
- Experience working in GMP QC Analytical laboratories that support aseptic sterile GMP manufacturing.
- Experience designing and executing risk assessments to support current and proposed QC testing operations.
- Attention To Detail
- Business Process Improvement
- Cell Therapy