Senior Director, Drug Substance Development and Manufacturing

• Direct and lead all process development, scale-up, technology transfer, and validation activities for peptide drug substance manufacturing across all Contract Development and Manufacturing Organizations (CDMOs)
• Establish and drive continuous improvement initiatives focused on enhancing manufacturing efficiency, enabling cost reduction, and establishing strategic redundancies across the CDMO network
• Define the long-term vision for manufacturing by maintaining a deep knowledge of industry trends, technological advancements, green manufacturing processes, and emerging regulatory changes
• Manage and enforce CDMO performance against key project timelines, deliverables, and costs
• Lead the negotiation and execution of complex technical agreements and work orders with CDMO partners
• Oversee budget planning and forecasting for all outsourced drug substance manufacturing activities
• Serve as the strategic lead for drug substance activities, driving seamless collaboration across Analytical Development, Formulation, Quality Assurance, and Regulatory Affairs
• Oversee the preparation and completion of drug substance modules (e.g., Module 3) for all regulatory dossiers (e.g., IND, NDA)
• Direct the preparation and final authorship of high-quality technical reports, executive summaries, and presentations to effectively communicate results and progress to internal leadership and external stakeholders

• Minimum of 10+ years of progressive, relevant experience in drug substance development and manufacturing
• Deep expertise in both synthetic and recombinant manufacturing approaches
• Hands-on experience with the synthesis and manufacturing of peptides is mandatory
• Demonstrated track record in managing clinical-scale supply, process characterization and optimization, technical transfers, and process validation activities
• Sound technical skills in applying scientific principles to complex process design, implementation, and successful technology transfer
• Solid knowledge of current Good Manufacturing Practices (cGMPs), Quality systems, and global regulatory requirements (e.g., FDA, EMA)
• Proven experience with the drafting, review, and authoring of CMC sections for major global regulatory submissions (e.g., IND, NDA, MAA)
• Exceptional solution-based critical thinking skills and the ability to operate with a keen sense of urgency and an entrepreneurial spirit
• Demonstrated ability to ensure accountability of self and others, coupled with strong detail-orientation to proactively identify and mitigate risks and issues
• Ability to strategically contribute to and manage multiple concurrent projects
• assess complex inter-relationships across various product development disciplines
• and identify critical gaps that may impact key milestones
• Proven success in building and maintaining strong, effective relationships with Contract Development and Manufacturing Organizations (CDMOs) to drive performance and manage risk
• Demonstrated ability to lead and contribute effectively to cross-functional teams to advance complex projects to completion
• Excellent verbal and written communication skills with a proven ability to build internal and external relationships and influence senior stakeholders
• Advanced degree in Chemistry, Chemical Engineering, or a related life sciences field

Experience in a small company or start-up environment is strongly preferred

• Comprehensive health benefits and tax-advantaged savings accounts
• Flexible time off, 13 paid holidays, and a companywide year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Disability and life insurance