Immunomedics, Inc.

Quality Control Manager/ Senior Manager (Viral Safety Manager)

Job Locations US-NJ-Morris Plains
Posted Date 3 weeks ago(5/13/2020 9:42 AM)
Job ID
2020-1681
# of Openings
1
Category
Quality

Overview

The Incumbent will be responsible for overseeing the Viral Safety testing and Viral clearance program at IMMUNOMEDICS for both commercial and pipeline products. Success in these areas will require strong technical/scientific and leadership skills, experience with all areas related to virology and the ability to project cross-functional influence in a GMP environment

Responsibilities

  • Works in a cGMP QC laboratory setting, responsible for testing and characterization of the Unprocessed Bulk, Cell banks, and End of Production cell Lines. Ensures timely delivery of test results to meet deadlines for delivery of accurate, verified release and stability data.
  • Will be responsible for design and execution of the viral clearance study at a Third Party provider in accordance with the regulatory guidance
  • Will be responsible for monitoring the new biosafety requirements, regulations and creating/ modifying existing policies / standards as necessary.
  • Will be steward of all biosafety testing related documents including SOPS, Material Specifications, Viral Safety Testing Policy and Viral response policy in the event of a suspected contamination event.
  • Performs SME review of viral safety testing related sections of all regulatory filing dossier. Provides technical input in response to any regulatory agency questions on biosafety testing issues.
  • Performs the comprehensive technical/SME review of all biosafety test reports from the Third Party Testing laboratory. Performs timely and accurate reviews laboratory results, proactively identifies and reports trends or suspect results, thoroughly investigates and documents laboratory events and investigations.
  • Effectively participates verification /  validation and technical transfer of analytical methods in compliance with FDA and ICH guidelines. Authors, reviews and approves analytical methods, validation protocols and technical reports.

Qualifications

  • Bachelor’s degree in biology or related discipline and 8 to 12 years of experience or advanced degree (PHD preferred) and 5 to 7 years of experience in virology and microbiological methods in a Biopharmaceutical and/or Biotechnology environment; or equivalent combination of education and experience.
  • Prior cGMP/GLP training and experience working in a cGMP/GLP environment required.
  • Extensive knowledge and proficiency with standard virology and microbiology methods and techniques.
  • Familiarity with adventitious agents and microbiological testing regulations and requirements as described in ICH, CFR, FDA Points to Consider, Pharmacopoeia and other guidance/regulations issued by WHO/EMA/FDA .
  • Need prior experience in viral clearance study design and thorough knowledge of the regulatory expectation
  • Experience in investigating and troubleshooting failures in biosafety tests including microbiological and virology based methods is a must.
  • Must have experience in working with third party providers
  • 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 in a high paced, highly demanding environment. 
  • Prior experience with a facility contamination response is a plus. Knowledge regarding facility decontamination procedures is also a plus
  • Must have familiarity with FDA and ICH guidelines of method validation, data integrity and be able to follow SOPs and cGMP guidelines. 
  • Must be proficient with MS Office applications. 

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