Senior Vice President, CMC

About the Role

A key member of the leadership team, the Senior Vice President, Chemistry, Manufacturing and Controls (SVP, CMC) reports directly to the CEO. This role provides vision, leadership, strategy, and management to oversee and expand the manufacturing of the company’s proprietary programs through preclinical, clinical, and commercial stages. The SVP of CMC will oversee the company’s entire outsourced manufacturing effort and ensure alignment with program progression.

The SVP, CMC translates corporate strategy into supportive strategies for global pharmaceutical manufacturing, fill/finish, packaging, supply chain, logistics, and quality control—including process development, analytical development, technology transfer, and validation—from early-mid stage product development through global commercial manufacturing. This role provides technical leadership, strategic direction, risk assessment, and oversight for long-range planning and execution across all supporting functions.

The position leads assessments and analyses to recommend contract manufacturing organization (CMO) qualifications and negotiations aligned with the global strategic plan. It ensures deliverables meet approved budgets, timelines, and adhere to international and national laws, guidelines, and quality control standards. The SVP, CMC has ultimate responsibility for the company’s supply chain and manufacturing strategy, as well as management of all technical operations to deliver products for clinical trials or market within defined regulatory, legal, quality, and cost standards.

The ideal candidate is a seasoned pharma/biotech executive with a proven track record in biologics R&D manufacturing, quality, supply chain management, and logistics, as well as experience in global submissions and maintenance of CMC sections for regulatory (BLA) filings. Candidates should have worked on biologics CMC development programs filed and approved by the FDA and other global regulatory bodies.

Responsibilities

• Leads, manages, and coordinates all outsourced manufacturing operations and budget for the company’s portfolio in collaboration with research, clinical development, and business teams.
• Develops and implements integrated CMC regulatory strategies for the company’s pipeline projects.
• Ensures a reliable supply of safe, high-quality drug products for preclinical, clinical, and future commercial needs, while addressing manufacturing strategies and capacity issues.
• Directs and manages external contract research and manufacturing operations, ensuring processes support clinical manufacturing.
• Serves as a communication nexus between executive leadership and technical teams, translating strategic plans into actionable tactical plans, setting priorities, measuring results, and driving continual improvement.
• Develops risk communication approaches, mitigation strategies, and project status updates for stakeholders, including the Board, to secure buy-in for recommendations.
• Oversees and manages technical leaders in pharmaceutical development, manufacturing, planning, procurement, logistics, production control, and quality control, defining deliverables aligned with corporate strategy and measuring performance.
• Gathers concerns, proposes solutions, and collaborates with the executive committee to adjust strategic plans as needed.

Requirements

• B.S. required; PhD preferred.
• Minimum of fifteen years’ experience in a senior management role in CMC, with increasing responsibilities.
• Strong record of accomplishments and leadership in biologics drug development and commercial manufacturing, preferably in a biotechnology company scaling from early-stage to commercial or near-commercial stage.
• Proven track record of establishing a global commercial product supply chain and successful interactions with regulatory agencies, demonstrated by timely global CMC submissions, approvals, and clinical/commercial supply of biologics.

Other Information

• Occasional evening and/or weekend commitments may be required.
• Domestic and international travel may be required.

Physical Demands

The physical demands described are representative of those required to perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities.

• Regularly required to sit, talk, or hear.
• Frequently required to use hands to finger, handle, or feel.
• Occasionally required to stand, walk, and reach with hands and arms.
• Must occasionally lift and/or move up to 10 pounds.
• Requires close vision and the ability to adjust focus for reading.

Work Environment

The work environment characteristics are representative of those encountered while performing the essential functions of this job, typically in an open office setting. Reasonable accommodations may be made for individuals with disabilities.

• Moderate noise level in the work environment.
• May require travel by plane or car.
• Involves working with biological and/or chemical hazards.

Pay

$306k–$445k base salary, with a 35% bonus target, 10% 401k match, and equity in the form of options and RSUs.