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Scientist II

Company: MacroGenics, Inc.
Location: Rockville
Posted on: September 17, 2021

Job Description:

Day to Day:

Our Client, a BioPharmecutical manufacturing company located in Rockville, MD, is looking to bring on an experienced Scientist II to their team. The Development Scientist II is responsible for the development of Drug Product (DP) formulation and manufacturing processes for the Companys pipeline molecules across early and late stage clinical and commercial development. They will design, execute, and analyze experiments to define parenteral dosage form and optimizes antibody-based formulations for intravenous and subcutaneous administration and primary container selection. They will also be responsible for supporting technology transfer activities to manufacturing sites, implementation of DP fill-finish process and control strategies with contract manufacturing organizations (CMO), and ensuring that manufacturing processes are sufficiently robust for successful process performance qualification (PPQ) campaigns and commercial manufacturing.


Relevant postdoctoral experience in protein formulation and/or process development

Lyophilization development of ADCs and bi-specific proteins, scale-up and technology transfer experience.

Prior experience in process performance qualification (PPQ) and authoring BLA(s).

Prior experience in technology and platform formulation and process development.
Must Have:

PhD and 3 years of related drug product formulation experience

Masters and 9 years of related drug product formulation experience

Bachelors and 11 years of related drug product formulation experience

Experience and/or knowledge in freeze/thaw, mixing, sterile filtration, vial and syringe filling and lyophilization

Keywords: MacroGenics, Inc., Rockville , Scientist II, Other , Rockville, Maryland

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