Immunomedics, Inc.

Director, Downstream Process Development

Job Locations US-NJ-Morris Plains
Posted Date 5 days ago(6/1/2020 11:13 AM)
Job ID
2020-1631
# 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.

Qualifications

  • Must be detail oriented with strong aseptic techniques and the ability to follow SOPs and have familiarity with cGMP regulations and conditions.
  • 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 Bachelor’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.

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