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Associate Director, Quality Control
Job Number: 2021-36915
Category: Biotechnology
Location: Mattapan, MA
Shift: Day
Exempt/Non-Exempt: Exempt
Business Unit: MassBiologics
Department: MassBiological Labs - MassBiologics of UMMS - W416800
Job Type: Full-Time
Salary Grade: 48
Num. Openings: 1
Post Date: March 26, 2021

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GENERAL SUMMARY OF POSITION:

Reporting to the Senior Director of Quality Control, The Associate Director, QC Operations will oversee the operations of the Quality Control laboratories, ensuring cGMP compliance in the testing of vaccine and other biologics products, providing strong technical leadership, meeting the organization’s priorities and goals in a timely and efficient fashion, maintaining continuous quality improvement of existing programs and contributing the development of quality control methods and protocols to address the needs of the investigational new drug program. 

 

MAJOR RESPONSIBILITIES:

  • Oversee Quality Control Laboratory including Chemistry, Raw Material, Component Control and Microbiology functions encompassing operations at two plant sites.
  • Assure operations are conducted in accordance with regulatory requirements and expectations.
  • Initiate hiring, performance reviews, and staff development activities to improve technical and management capabilities, maintaining career development for QC Analysts and professional development for QC Managers.
  • Develop, review and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation and stability studies; Design and implement new methodologies to increase efficiencies and productivity
  • Assists QC staff in developing solutions to complex technical and regulatory problems including the investigation and reporting of out of tolerance and/or out of specification reporting
  • Participate in interdepartmental meetings and discussions to contribute to and respond do the organizations strategic and operational needs.
  • Performs additional duties as required.

 

REQUIRED QUALIFICATIONS:

  • Master’s degree or higher degree with 6+ years of relevant experience is preferred OR
  • 4 years previous management experience with demonstrated track record of successful leadership in a biopharmaceutical or equivalent environment.
  • Must be detail oriented with effective technical writing and verbal skills, and capable of simultaneous contribution to a wide range of scientific and technical disciplines covered by the QC laboratories.
  • Must have direct experience with cGMP documentation systems and with implementation of quality control systems, including change systems.
  • Must have strong knowledge of FDA cCMP/cGLP manufacturing, regulatory and quality systems regulations and assay, analyst, laboratory and facility requirements.
  • Experience in several of the following areas strongly preferred.
    •  Production and quality control of bacterial vaccine products, production and quality control of monoclonal antibodies;
    • analytical method development, transfer and validation; environmental monitoring and other aspects of QC microbiology;
    • testing and release of raw materials for manufacture of biologics, analytical chemistry and biochemistry;
    • serological assays – particularly cell-based assays, in vivo potency assays and cell culture
    • specific technologies/methods including HPLC, FITR, Atomic Adsorption Spectroscopy, ELISA, RT-PCR, and Capillary Electrophoresis; 
  • Experience of working with both IND products and licensed drug products preferred.
  • Bachelor’s degree with 10+ years of relevant experience. 

SUPERVISION EXERCISED:

Responsible for supervising lower level personnel.

 

ENVIRONMENTAL WORKING CONDITIONS:

Job may involve working with or near toxic or infectious materials.  Employee will be required to follow MBL infection Control plan as required by OSHA.

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