Immunomedics, Inc.

Quality Control Laboratory Manager

US-NJ-Morris Plains
1 month ago
Job ID
2017-1032
# of Openings
1
Category
Scientific Manufacturing/Production

Overview

Manage a department of 7-10 analytical staff responsible for QC testing of biopharmaceutical product intermediate, bulk and drug product, providing leadership, and managing performance. Support transfer and validation of robust analytical methods to be used for release testing for antibody-related medicines. Maintain laboratories in a state of GMP readiness.

Responsibilities

  • Manage the activities of supervisory and analytical staff in a GMP QC laboratory testing environment, schedule and assign/prioritize laboratory activities aligned with organizational goals.
  • Support laboratory staffing; provide input on hiring decisions, access to training and manage performance and development of staff.
  • Ensure the laboratory is properly equipped, provide recommendations for instrument acquisition and assume accountability for ensuring all laboratory systems are appropriately qualified and maintained.
  • Represent QC cross-functionally, provide technical subject matter expertise and apply sound scientific judgement based on experience and knowledge of laboratory operations.
  • Includes accountability for thorough, well documented and timely laboratory deviation/investigation reporting
  • Effectively utilize Change Management, develop and execute continuous improvement initiatives within QC.
  • Coach and mentor staff, oversee effective utilization of all quality management systems by laboratory personnel, develop and maintain compliance metrics and report to management
  • Maintain and improve Quality Control GMP compliance and documentation, ensure integrity of QC data for support of regulatory submissions.

Qualifications

  • Bachelor’s degree in chemistry, biology, or related disciplines and 7-10 years of experience in a Pharmaceutical (Biologics), Biopharmaceutical, and/or Biotechnology environment; or equivalent combination of education and experience. 
  • Prior experience working in a cGMP/GLP environment required. 
  • Solid knowledge and proficiency with analytical methods currently used for purity, potency identity, and impurities testing for release and stability of biopharmaceutical products.
  • Assists in development and implementation of analytical method validation based on FDA and ICH guidelines.
  • Must possess excellent communication (oral and written), organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
  • Must be able to work in a team environment and perform job responsibilities under minimal supervision. 
  • Must have familiarity with FDA and ICH guidelines and be able to maintain laboratories in a state of compliance with cGMP guidelines. 
  • Must be proficient with MS Office applications. 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed