Immunomedics, Inc.

Manager, Quality Control Data Review

Job Locations US-NJ-Morris Plains
Posted Date 1 month ago(5/4/2020 3:09 PM)
Job ID
2020-1679
# of Openings
1
Category
Quality

Overview

Manages QC staff responsible for the day to day data review function of QC testing of biopharmaceutical product and intermediate, bulk drug substance and drug product, provides leadership and manages performance. This position supports cGMP release and stability testing of product, transfer and validation of analytical methods. Maintains laboratories in a state of GMP readiness.

This Quality Control Data Review Manager is a subject matter expert on review of documentation associated with the operation of a cGMP QC laboratory. Responsibilities include the application of uniform practices for review of analytical raw data and electronic data in the analytical laboratory supporting batch release, stability, cleaning verification, raw materials release, method qualification and method transfer activities. Routine inspection of laboratory documentation for compliance with current industry standards is also within scope.

Responsibilities

  • Reviews cGMP Analytical data generated during testing to support product release, stability and facilities monitoring using HPLC, UPLC, Capillary Electrophoresis and wet chemistry methods. Ensures that standards for documentation and comply with SOPs (analytical methods and Good Documentation Practices) and industry standards.
  • Strong technical knowledge including an understanding of laboratory procedures, methodology and standards. A minimum of three years of QC analytical laboratory experience is preferred.
  • Review laboratory logbooks, labeling and other documentation to ensure conformations with SOPs and industry guidelines. Provides technical support for monitoring and evaluating the performance of analytical methods to demonstrate ongoing method suitability.
  • Compile and summarize analytical raw data in various physical and electronic report formats.
  • Experience with deviations, change controls and CAPA’s.
  • Reviews protocols, analytical reports and certificates of analysis.
  • Provides guidance and training to QC personnel to support company training in the procedures used to effectively execute testing.
  • Participates in compliance-focused teams working towards the goal of continuous improvement of laboratory documentation practices.
  • May coordinate and track progress of analytical testing internally or at CROs.
  • Maintains QC laboratory metrics.
  • Ability to establish robust QC systems.
  • May participate in regulatory agency audits and inspections
  • It is each employee’s responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee’s responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function.

Qualifications

  • M.S. degree in Biochemistry, Chemistry, Molecular Biology or a related field, and five (5) years relevant experience or B.S. degree and 7-10 years of relevant GMP lab experience with biotherapeutics. Experience in a regulated biopharmaceutical environment with analysis of biological molecules is preferred.
  • Three to five years of experience reviewing pharmaceutical data in a GMP-regulated QC laboratory.  Experience with HPLC / UPLC, spectrophotometers, capillary electrophoresis and compendial methods is preferred.
  • Knowledge of QC laboratory test procedures, cGMP requirements, ICH/USFDA guidelines, USP Compendial methods, raw material analysis, method validation guidelines, analytical method transfers, finished products, and stability testing.
  • Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP.
  • Familiarity with regulatory guidance documents from FDA, EMEA and ICH.
  • Ability to operate independently where appropriate, yet escalate issues as appropriate, establish effective cross functional working relationships.
  • Strong attention to detail is essential. Well-developed organizational, interpersonal communications, writing, and strong listening skills are required.
  • Must have ability to prioritize and manage multiple, concurrent projects with often long-life cycles.
  • Must be able to recognize the impact beyond a single site, project or collaboration.
  • Must have strong verbal, technical writing and presentation skills.
  • Ability to establish and maintain laboratory metrics.
  • Direct experience with QC laboratory systems is a plus.
  • Must have expert authorship of technical documents.
  • Works well in collaboration with other teams.

Options

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