Immunomedics, Inc.

Director, Drug Product and Formulations Development

Job Locations US-NJ-Morris Plains
Posted Date 5 days ago(6/1/2020 11:14 AM)
Job ID
# of Openings
Process Sciences


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


  • Lead the development of stable formulations (liquid and/or lyophilized) for antibodies and antibody drug conjugates.
  • Lead the development/optimization of scalable, efficient and cost-effective conjugation and purification of ADCs.
  • Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions.
  • Participation in laboratory bench work as needed (small department).
  • Oversee the development of technical transfer protocols and supervise the transfer of drug product manufacturing processes into a cGMP drug product manufacturing facility.
  • Be responsible for the technical management of third party drug product manufacturers.
  • Provide technical support for commercial manufacturing activities.
  • Work closely with other scientists and associates in the Process and Manufacturing Sciences Department to assess product quality and product stability.
  • Represent the Drug Product group on Program Teams and/or subteams.
  • Provide mentoring for associate scientists.
  • Provide organizational leadership in all areas related to formulation, fill & finish work.
  • Work collaboratively and cross-functionally with other key leaders to ensure the proper execution of organizational goals.
  • Assign resources according to priority and project needs.
  • Provide data and metrics across the department and to senior management on a regular basis.


      • PhD in the biology or chemistry-related disciplines and 10+ years industry experience or a BS/MS and 15+ years industry experience.
      • Extensive prior experience in the process development and clinical or commercial cGMP production of antibody or antibody-related products.

  • Lead a team of 2 – 3 scientists in the Drug Product group of Process and Manufacturing Sciences.
  • Extensive experience with formulation development for liquid, frozen and lyophilized drug products and intermediates, from study design to analytical evaluation.
  • Strong familiarity of the collection of analytical techniques that support the formulation, fill/finish process development work.
  • Written and oral communication. Authoring of protocols, reports and parts of regulatory filings. Internal and external presentations.
  • Fluency in the regulatory guidance documents that touch upon drug product fill/finish and stability requirements.
  • Solid understanding of cGMPs and compliance requirements.

Prior experience interacting with the FDA during inspections.


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