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Associate Scientist - Formulation - CMCApply Now

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Employment Type: Contract

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Job Description

Contract Length:  6+ months; remote position

Job Summary:  The position is responsible for drug product process development, characterization, technology transfer and validation at CDMOs. The incumbent will review manufacturing documentation and provide technical support for clinical manufacturing.

Responsibilities:
 
  • Work with CMOs to scale up Drug Product manufacture, including formulation fill-finish
  • Design and perform stability studies of experimental and clinical batches
  • Perform GMP data audits of batch records and manufacturing procedures.
  • Contribute to reports and/or provide documentation for regulatory submissions.

Requirements:
 
  • Master’s degree in Chemistry or related discipline and 7 years of work experience in biotech/pharmaceutical industry preferred. Bachelor’s degree in Chemistry or related discipline and 10 years of work experience in biotech/pharmaceutical industry preferred.
  • Demonstrated knowledge in drug product development, characterization, and fill-finish operations.
  • Experience developing scale-up protocols and methodologies.
  • Manufacturing and development experience in Vial and PFS of biologics
  • Strong background in authoring and reviewing manufacturing documentation.
  • Excellent time management skills and the ability to work with a sense of urgency.
  • Experience in technology transfer to external contract organizations and collaborators
  • Strong oral and written communication including the ability to present information clearly and logically.

Contact

Jared Potter
Principal Recruiter

He's a natural people person.


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