Senior/Executive Director, CMC

SciPro; United States; Remote; USD 260,000 - 285,000; Full time

Job summary

SciPro seeks a Senior Director/Executive Director for a biotech focused on small molecule oncology. You will lead CMC activities, manage external vendors, and ensure compliance with regulatory standards in a dynamic environment. An ideal candidate has extensive experience in biopharmaceutical CMC development and proven leadership in clinical manufacturing transitions.

Qualifications

• 15+ years of CMC development experience in biopharmaceuticals.
• Proven track record in small molecule oncology.
• Deep knowledge of GMP regulations.

Responsibilities

• Lead and manage CMC activities related to small molecule clinical programs.
• Oversee manufacturing and supply for clinical trials.
• Develop and execute CMC strategies aligned with regulatory requirements.

Skills

Leadership

Strategic Thinking

Communication

Problem Solving

Education

PhD or MS in Chemistry, Pharmaceutical Sciences, Chemical Engineering

Job description

This range is provided by SciPro. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$260,000.00/yr - $285,000.00/yr

Direct message the job poster from SciPro

Specialist Recruitment Consultant | Technical Operations

We are supporting a clinical stage Small Molecule Oncology Biotech on a remote Senior Director/Executive Director, CMC. The ideal candidate will have small molecule oncology commercialization experience in a start up environment

Key Responsibilities:

• Lead and manage all CMC activities related to small molecule clinical programs, including process chemistry, formulation development, analytical method development, and validation.
• Oversee manufacturing and supply of drug substance (API) and drug product to support ongoing and future clinical trials.
• Develop and execute CMC strategies aligned with regulatory, quality, and clinical development goals.
• Manage and select CDMOs, CROs, and other external vendors to ensure quality, timelines, and budget compliance.
• Partner cross-functionally with Regulatory Affairs, Clinical Development, Quality Assurance, and Program Management to ensure alignment on CMC deliverables and strategy.
• Author and review CMC sections of regulatory filings (IND, IMPD, NDA, MAA, etc.) and represent CMC function in regulatory interactions with global health authorities.

.

Qualifications:

• PhD or MS in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.
• 15+ years of experience in CMC development within the biopharmaceutical industry, with a strong focus on small molecule oncology products.
• Proven leadership in advancing programs through clinical development into late-stage or commercial manufacturing.
• Deep knowledge of GMP regulations, quality systems, and global regulatory requirements (FDA, EMA, etc.).
• Demonstrated success in leading external manufacturing relationships (CDMOs, CROs) and managing complex supply chains.
• Excellent communication, strategic thinking, and problem-solving skills.
• Comfortable working in a fast-paced, matrixed, and collaborative environment.

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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