Immunomedics, Inc.

  • Director, Downstream Process Development

    Job Locations US-NJ-Morris Plains
    Posted Date 3 weeks ago(9/28/2018 2:00 PM)
    Job ID
    2018-1316
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    Responsible for leading the purification process development and validation of all commercial and clinical products under cGLP and cGMP guidelines.

    Responsibilities

    • Develops and qualifies/validates purification process for all commercial, clinical and preclinical materials.
    • Writes and supervises/executes protocols and reports according to the current GMP guidelines.
    • Trends process development, validation and manufacturing data and improve processes.
    • Generates SOPs and batch records for new processes.
    • Trains and cross-trains process validation and manufacturing personnel during tech transfer.
    • Technology transfers of downstream processing to CMOs and partners.
    • Interacts with Manufacturing, Quality Assurance and Compliance, Quality Control and Regulatory Affairs and helps with CMC regulatory submissions.
    • Follows appropriate guidelines and is able to work under cGLP for development and cGMP for manufacturing/validation.
    • Supervise the purification and delivery of research materials.
    • Carries out direct supervisory responsibilities in accordance with the department-set goals.
    • Carries out direct supervisory responsibilities in accordance with the department-set goals.   Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution.

    Qualifications

    • Master’s or Ph.D. degree in biology, chemistry, engineering or related field, with 7+ years of experience in product/downstream process development and validation; or Batchelor’s degree with at least 15+ years of related experience; or equivalent combination of education and experience.
    • Experience with downstream process development and/or downstream manufacturing of monoclonal antibodies.
    • Must have a strong background of chromatography and filtration processes commonly used in antibody manufacturing, including a deep understanding of the nuances and challenges of process scale and scale-down modeling.
    • Must have strong leadership skills; possess excellent communication (oral and written), organizational, and interpersonal skills, with the ability to perform in a team environment;
    • Must be detail oriented with strong aseptic techniques and the ability to follow SOPs and have familiarity with cGMP regulations and conditions

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