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.
