Associate Director Drug Substance
Meet - newark, NJ
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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 organicpeptide chemistry (7+ years) or MS in organicpeptide 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 FDAICHcGMP 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.
Created: 2024-10-05