Associate Director Drug Substance

3 months ago


newark, United States Meet Full time

We are looking for a skilled API process research and development chemist to lead peptide development, route scouting, and scale-up. The role involves managing peptide process research, large-scale production, and technology transfer to CDMOs.


Key Responsibilities:

  • Identify scalable peptide and amino acid manufacturing routes and communicate findings effectively.
  • Develop and execute strategies for raw materials and drug substances to meet global regulatory standards.
  • Manage CDMO partnerships for sourcing and large-scale peptide API production.
  • Evaluate and select third-party contractors and suppliers.
  • 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.

Qualifications:

  • 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.
  • Detail-oriented, self-driven, with strong multitasking abilities and innovative problem-solving skills.



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