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QC Analytical Technical Lead * job in Gaithersburg at Experis

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QC Analytical Technical Lead * at Experis

QC Analytical Technical Lead *

Experis Gaithersburg, MD Full-Time
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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


Job Title:

QC Analytical Technical Lead


Client Location:

Gaithersburg MD 20878 United States


Role:

Onsite

Responsibilities:

  • 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.

Qualification:

  • 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.

Apply Today!

Recommended Skills

  • Asepsis
  • Attention To Detail
  • Biology
  • Business Process Improvement
  • Cell Therapy
  • Communication
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