Drug CMC Lead

About This Opportunity

We are representing a confidential clinical-stage therapeutics company developing innovative at-home care solutions. Our client is advancing a novel combination product through the regulatory pathway and seeks an experienced CMC Lead to drive drug development and manufacturing strategy.

Reporting to executive leadership, you will own Chemistry, Manufacturing & Controls (CMC) strategy and operations for the drug and combination product portfolio. This leader will advance the lead asset through the NDA regulatory pathway while coordinating cross-functional efforts integrating drug formulation, analytical strategy, and manufacturing with medical device components.

Responsibilities

• CMC Program Leadership: Oversee drug substance and drug product development at CDMOs, including formulation optimization, stability, and device compatibility
• Set technical requirements and acceptance criteria for drug quality attributes, drug-device interface compatibility, and analytical performance
• Manage analytical method development, validation, and qualification for release and stability testing
• Define comparability strategies for clinical and commercial lots, bridging legacy formulations to scaled, controlled processes
• Manufacturing & Supply Chain: Serve as primary point of contact for CDMOs and suppliers
• Select and manage CDMOs for drug substance and drug product manufacture; negotiate statements of work and ensure timeline alignment
• Drive technology transfer, scale-up, GMP manufacturing, and stability programs
• Implement rigorous quality systems ensuring cGMP compliance and regulatory inspection readiness
• Strategy & Regulatory: Lead CMC strategy development and execution to support IND and eventual NDA submission
• Define regulatory pathways and advise on evidence needs in partnership with regulatory affairs for drug and combination products
• Engage with FDA and other regulatory authorities on CMC components of submissions
• Cross-Functional Collaboration: Partner with clinical operations, regulatory affairs, quality assurance, device engineering, and external partners to align on timelines and risk mitigation
• Serve as core member of product leadership team, providing CMC insight for strategic decisions and clinical planning
• Mentor team members and promote best practices across functions

What We're Looking For

• Advanced degree preferred in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field
• 10+ years of drug development experience with demonstrated CMC strategy leadership in biotech/pharmaceutical settings
• Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and quality compliance
• Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements
• Experience scaling products from early clinical through pivotal and commercial manufacturing
• Exceptional leadership and management skills with excellent communication and problem-solving abilities
• Ability to thrive in a fast-paced, dynamic startup environment
• Preferred: Proven track record managing CMC for combination products (drug + delivery device)
• Preferred: Successful FDA interactions on CMC topics and experience through regulatory inspections

How We Work with You

Candidates apply directly through Get A Job.ai. Our recruiting team will conduct an initial screening to understand your background and interest. Qualified candidates will be submitted to our client for consideration. Please do not contact the client directly, as all communication is managed through our talent team to ensure a professional and confidential process.

Pay

Pay via Get A Job.ai: $150,000 - $215,000 salary plus equity options. This is a full-time position based in the USA.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices and considers all qualified applicants regardless of race, color, religion, sex, orientation, national origin, age, disability, genetics, or any other protected basis.