Immunomedics, Inc.

  • Quality Control Manager, Stability

    Job Locations US-NJ-Morris Plains
    Posted Date 3 months ago(9/19/2018 9:46 AM)
    Job ID
    2018-1317
    # of Openings
    1
    Category
    Quality
  • Overview

    The Quality Control Manager, Stability will be responsible the stability programs for all clinical and commercial biologic process intermediates, drug substances and drug products across internal and external manufacturing sites. The manager is responsible for the Immunomedics’ global product stability strategy and manages internal logistical and technical operations for QC that includes site sample management.

    Responsibilities

    • In conjunction with the Head of Quality Control, provide leadership and shape the strategic direction of a multi-site stability program and the site Sample Management team through ownership and implementation of cGMP Laboratory principles and system level enhancement.
    • Develop a global stability program that ensures alignment of stability studies executed at contract sites with ICH standards, internal requirements and the company’s regulatory strategy.
    • Manages the daily operation of a biologics QC group responsible for global product stability, including ownership of the site stability program for monoclonal antibody products.
    • Develops stability documentation that supports product retest / expiry dating and storage conditions. Provides oversight for timely stability data trending, detection and reporting of trends and leads investigations in response to unusual or unexpected results or deviations.
    • Ensures the development, implementation and execution of effective processes for local sample handling procedures, retain and reserve sample collection and storage.
    • Leads a team that owns the site sample management program and provides direct support for antibody manufacturing and testing laboratories.
    • Defines departmental roles and accountabilities, hires, integrates and develops high quality talent capable of delivering against the department’s goals and objectives.
    • Establishes and communicates performance objectives for QC Stability and Sample Management staff that are consistent with the businesses unit goals, and site Quality objectives.
    • Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that attracts, develops and retains the best talent.
    • Ensures that all QC Stability and Sample Management personnel are provided adequate training, education and experience to perform their GMP related job function effectively.
    • Participates in compliance related teams working towards the goal of continuous improvement.
    • Participates in the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
    • Verifies compliance with applicable Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
    • Carries out direct responsibilities in accordance with the department-set goals.  Responsibilities include interviewing and onboarding; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution.

    Qualifications

    • Bachelor’s degree in a Life Sciences discipline or equivalent required.
    • Minimum of five (5) years relevant experience in analysis and Quality Control of biological molecules.
    • Minimum of three (3) years of leadership/supervisory experience.
    • Strong knowledge of cGMP and cGLP regulations, safety and environmental requirements. Experience with laboratory information management systems (LIMS) and other related digital quality tools highly preferred
    • Must have expert cGMP, Quality Control and risk management knowledge that will positively impact QC Stability and Sample Management staff and their deliverables.
    • Must be able to critically interpret data and through use of statistical trending tools, effectively communicate issues to management with clarity and a high level of brevity and accuracy.
    • Must be able to recognize and direct resolution of Quality Control issues and compliance risks.
    • Must manage independently, support decisive tactical and strategic decisions within the department, contribute to strategic decisions within QC and set priorities for the department.
    • Must be a technical/scientific and compliance expert. Must be able to measure technical/scientific attributes and drive science-based decisions across the organization.
    • Must have expert authorship of technical documents. Must be able to recognize the impact beyond a single site, project or collaboration.
    • Must have strong verbal and written communication skills.

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