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 requires strategic oversight of drug substance development and collaboration with external contract manufacturing organizations (CMOs) to ensure robust and scalable processes.

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 guidelines and regulatory submission processes
• Proven leadership experience, including managing relationships with CMOs

Responsibilities

• Lead and mentor a high-performing team, providing clear direction and feedback
• Define and implement drug substance and analytical development strategies
• Oversee drug substance process development in collaboration with external CMOs
• Establish and enhance internal laboratory facilities for development execution
• Foster cross-functional collaboration to achieve program goals

Skills

• Strong scientific foundation with a collaborative leadership style
• Ability to navigate complex challenges with sound judgment
• Excellent communication and partnership-building skills

Education

• PhD in a relevant scientific discipline

Tools

• Knowledge of state-of-the-art technologies for synthetic peptide manufacturing and analytical methods