Senior Manager CMC (Drug Product & Drug Substance)

Job Title: Senior Manager CMC
Location: Remote

Role Overview

We are looking for a strategic & scientific leader with a strong background in CMC (emphasis on Formulation & Process Development) to lead and oversee all aspects of our small molecule CMC initiatives throughout preclinical and clinical development. This role involves close collaboration with external manufacturing partners and internal teams to ensure the seamless delivery of drug substance and drug product, regulatory compliance, and supply chain coordination.

Key Responsibilities

• External Partner Management: Select and manage relationships with CDMOs for drug substance, drug product, and analytical services. Oversee process development, manufacturing activities, and documentation review.
• Regulatory Compliance: Ensure all CMC operations align with global regulatory standards (FDA, EMA, ICH) and adhere to GMP/GLP guidelines.
• Quality Assurance: Partner with the quality team to maintain high standards across all vendors and ensure compliance with internal and external quality expectations.
• Regulatory Documentation: Lead the drafting and submission of CMC sections for regulatory filings, including INDs, IMPDs, and other global submissions.
• Cross-Functional Collaboration: Work closely with discovery, nonclinical, clinical, regulatory, and external CRO teams to support program goals and timelines.
• Clinical Supply Oversight: Coordinate with CDMOs and logistics partners to ensure timely availability of clinical and nonclinical study materials.
• Reporting: Provide regular updates to leadership, including monthly in-person presentations and weekly virtual briefings.
• Vendor & Budget Oversight: Identify and manage external partners, track contracts and budgets, and ensure project milestones are met with a focus on quality and risk management.
• Innovation & Trends: Stay informed on emerging technologies and regulatory changes in the pharmaceutical manufacturing landscape.

Qualifications

• Ph.D in a relevant scientific discipline and at least 5 years of experience in the pharmaceutical/biotech industry, with expertise in both drug substance and drug product.
• Minimum of 3 years managing CRO/CDMO vendors and external manufacturing partners.
• Proven experience with regulatory submissions (e.g., INDs, IMPDs, NDAs, MAAs).
• Strong knowledge of global regulatory frameworks and ICH guidelines.
• Familiarity with GxP standards and best practices.
• Excellent leadership, communication, and organizational skills.
• Ability to thrive in a fast-paced, evolving environment.
• High ethical standards and a strong professional reputation.