What You’ll Do:

We are seeking an accomplished and strategic Senior Director, Drug Substance Development and Manufacturing to lead and oversee all outsourced drug substance manufacturing operations.

Reporting directly to the Vice President, Drug Substance Development and Manufacturing, this key leadership role is accountable for driving technical excellence across the manufacturing lifecycle, including process development and continuous improvement, clinical supply manufacturing, and ensuring commercial preparedness and validation.

The ideal candidate is an experienced leader with a deep technical understanding of peptide drug development and significant experience with both synthetic and recombinant manufacturing techniques for peptides and/or peptide fragments. Success in this role requires a high degree of collaborative leadership, effectively managing and driving complex programs through internal cross-functional teams and external Contract Development and Manufacturing Organizations (CDMOs).

Required location: Waltham, MA or San Diego, CA (hub-based, onsite 3-4 days per week)

Responsibilities:

• In collaboration with senior leadership, 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), ensuring strategic alignment and operational excellence
• 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 to ensure a competitive and compliant strategy
• Manage and enforce CDMO performance against key project timelines, deliverables, and costs, holding partners accountable to agreed-upon expectations
• Lead the negotiation and execution of complex technical agreements and work orders with CDMO partners, ensuring clarity and successful delivery of manufacturing campaigns
• 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 to ensure cohesive program execution
• Oversee the preparation and completion of drug substance modules (e.g., Module 3) for all regulatory dossiers (e.g., IND, NDA), partnering closely with Regulatory Affairs to ensure timely and compliant global submissions
• 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

Required Qualifications:

• Minimum of 10+ years of progressive, relevant experience in drug substance development and manufacturing. This must include 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
• Regulatory Knowledge: 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, focused on the successful execution of complex drug development plans
• 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

Preferred Qualifications:

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

Education:

• Advanced degree in Chemistry, Chemical Engineering, or a related life sciences field