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Principal Scientist/Associate Director, Oral Solid Dose Formulation

Posted ungefähr 2 Monate her

  • Contact: Naomi Gale
  • Contact Email:
  • Contact Phone: 929-379-0799
  • Expiry Date: 01 April 2023

​SciPro has recently partnered with a globally renowned pharmaceutical company’s small molecule startup team on a Process Development Principal Scientist (AD level) search. This small molecule team is currently supporting rapid pipeline development with a vision to revolutionize the treatment options for individuals with rare diseases. This team offers all the benefits of a startup's team culture while also providing strong backing as a highly-ranked large pharma company. The company is looking to bring on a OSD Formulator to contribute the continued growth of their small molecule programs.

Position Requirements:

  • Advanced degree in Pharmaceutical Sciences/Chemical Engineering, or other relevant life sciences concentration with 6+ years of industry experience

  • Technical expertise in oral solid dosage product formulation development

  • Highly experienced in cGMP & pharmaceutical regulatory guidelines

  • Technical understanding of modeling and simulation related to product development

  • Experience with amorphous and/or spray dry dispersions

  • Experience authoring CMC modules of NDA/MAA submissions

  • Process Development experience for small molecules, oligonucleotides, and/or peptides

  • Late-stage manufacturing experience (process validation and optimization) is a major plus!

What you’ll be doing:

  • Contributing to the OSD Drug Product team in executing all development goals and operations

  • Supporting drug product formulation operations for company programs (small molecules and oligonucleotides)

  • Working cross-functionally with DS/QC/QA/AD teams to troubleshoot product development criteria and support CMC program development

  • Ensuring GMP compliance both internally and externally

  • Contributing to the development of advanced process modeling solutions and control strategies

If this role aligns with your skillset and career goals, please apply below!