Director of Drug Substance and Analytical Development (Pharmaceuticals, Onsite)

Job summary

The role involves leading a team focused on the development of synthetic peptide drug substances and analytical methods from early research through Phase 2. The position is key in defining strategies and ensuring robust processes in collaboration with external partners.

Qualifications

• PhD in chemistry, biochemistry, pharmaceutical sciences, or a related field
• Over 10 years of experience in the pharmaceutical industry, particularly in Chemistry, Manufacturing, and Controls (CMC)
• Expertise in synthetic peptide drug substance development and analytical method development relevant to peptide APIs
• Strong understanding of GMP, regulatory guidelines, and submissions
• Proven leadership experience, including managing relationships with contract manufacturing organizations (CMOs)

Responsibilities

• Lead and develop a high-performing team through effective direction, coaching, and resource management
• Define and implement drug substance and analytical development strategies from early research to Phase 2
• Oversee drug substance process development with external CMOs, including planning and key technical decisions
• Establish and enhance internal laboratory facilities to improve development execution and scientific capabilities
• Foster collaboration across projects and teams, contributing scientifically to achieve program objectives

Skills

• Strong leadership and team-building abilities
• Excellent communication and collaboration skills
• Ability to navigate complex challenges with sound judgment
• Goal-oriented mindset with a proactive approach

Education

• PhD in a relevant scientific discipline

Tools

• Familiarity with state-of-the-art technologies in synthetic peptide manufacturing and analytical methods