About the Company
We are representing a rapidly advancing, clinical-stage biotech company committed to developing transformative therapies for patients with rare bleeding and thrombotic disorders. With operations in both the U.S. and Europe, this company offers an entrepreneurial and science-focused environment where innovation, impact, and collaboration are central. As part of their strategic growth, they are seeking a Vice President, CMC – Drug Substance to lead a key function within their Chemistry, Manufacturing, and Controls (CMC) organization.

Role Overview
Reporting to the SVP, the Vice President, CMC – Drug Substance will be the company’s senior leader responsible for all aspects of drug substance development and manufacturing across a pipeline of advanced peptide- and biological therapies.
This individual will work closely with peer leaders overseeing Drug Product and Analytical Development to form an integrated, forward-thinking CMC leadership team. The role includes strategic oversight, vendor management, regulatory contribution, and team development in support of early- and late-stage development activities through to commercialization.

Key Responsibilities
Strategic Leadership

• Define and lead the Drug Substance strategy across the development pipeline, aligned with project needs and corporate goals.
• Serve as the principal subject matter expert on peptide and biological drug substance development, manufacturing, and scale-up.
• Collaborate closely with Drug Product and Analytical Development leads to ensure alignment and end-to-end CMC integration.

Process Development & Technical Oversight

• Oversee process design, optimization, scale-up, and tech transfer of drug substance processes to CDMOs.
• Ensure robust, scalable, and regulatory-compliant manufacturing routes using Quality by Design (QbD) principles.
• Drive the implementation of innovative technologies to improve efficiency, quality, and cost of goods.

CDMO & Vendor Management

• Lead the selection, management, and oversight of external manufacturing partners, ensuring performance, compliance, and alignment with project timelines.
• Serve as the technical lead for all DS-related external collaborations, including acting as Person-in-Plant when necessary.
• Build and maintain a strong network of CDMOs, raw material suppliers, and consultants.

Regulatory & Compliance

• Lead the preparation of Drug Substance CMC sections for global regulatory submissions (IND, CTA, BLA, MAA).
• Support regulatory agency interactions and inspections as the DS subject matter expert.
• Partner with Quality to ensure compliance with global cGMP requirements and company standards.

Team Leadership & Organizational Development

• Build, lead, and mentor a high-performing Drug Substance development team.
• Drive the establishment of internal capabilities where strategically and economically viable.
• Contribute to budgeting, planning, and strategic resourcing for Drug Substance activities.

Cross-functional Collaboration

• Represent Drug Substance CMC on cross-functional program teams.
• Provide technical support for business development, due diligence, and partnership discussions.

Qualifications

• Advanced degree (PhD or MSc) in chemistry, biochemistry, chemical engineering, or related field.
• 15–20+ years of CMC experience with a strong focus on Drug Substance process development and manufacturing.
• Deep expertise in peptide development is required; experience with siRNAs is a strong plus.
• Proven leadership in managing global CDMO relationships, technology transfers, and regulatory submissions.
• Strong working knowledge of FDA, EMA, and ICH guidelines and regulatory expectations for DS CMC.
• Excellent communication, negotiation, and project management skills.
• Comfortable working in a fast-paced, dynamic biotech setting with a hands-on and collaborative approach.
• Willingness to travel internationally (up to 20%).