Senior Peptide Development Chemist

4 weeks ago


Newark, New Jersey, United States Meet Full time
Lead Peptide Development and Scale-Up

We are seeking a highly skilled chemist to lead peptide development, route scouting, and scale-up. The ideal candidate will have expertise in peptide process research and large-scale production, as well as experience in managing partnerships with CDMOs.

Key Responsibilities:

  • Develop and execute strategies for raw materials and drug substances to meet global regulatory standards.
  • Collaborate with analytical scientists to monitor process changes' impact on yield and impurities.
  • Work with toxicology to identify and qualify impurities.
  • Document all lab and scale-up activities and stay updated on relevant scientific literature.

Requirements:

  • PhD in organic/peptide chemistry (7+ years) or MS in organic/peptide synthesis (10+ years) with relevant experience.
  • Experience in process performance qualification and early commercial manufacturing is a plus.
  • Proficiency in QbD and DoE methodologies.
  • Strong knowledge of FDA/ICH/cGMP guidelines and regulatory CMC filings.
  • Proven leadership with internal and external resources, strategic problem-solving skills, and excellent teamwork.


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