RA Stealth Co - Director/Senior Director CMC

About Stealth Co

Stealth Co is a clinical-stage biotechnology company advancing novel prophylactics with broad potential across respiratory and infectious diseases. Stealth co operates with a focused, execution-driven team and is progressing a differentiated antiviral program through clinical development.

We are seeking a Director or Senior Director of Chemistry, Manufacturing, and Controls (CMC) to lead strategy and execution across all aspects of drug development and manufacturing. This individual will play a central role in enabling clinical readiness and supporting long-term scalability through expert leadership in formulation, process development, external partnerships, and regulatory alignment. Candidates located in the Northeastern U.S. are preferred, along with a willingness to travel to the EU as needed.

Key Responsibilities

CMC Strategy & Clinical Readiness

• Lead all CMC activities from early clinical development through commercial readiness, including process development, scale-up, and tech transfer.
• Define clinical supply strategy for both drug substance (DS) and drug product (DP) to support Phase I/II development.
• Oversee formulation development and optimization, analytical method development and validation, stability studies, and comparability assessments.

Drug Product (DP), Process Development & Formulation

• Own formulation optimization planning to align with target product profile (TPP), tolerability, pharmacokinetics, and stability requirements.
• Develop and scale drug product manufacturing processes to support GMP supply for Phase I/II clinical trials.
• Lead formulation–device integration activities, including compatibility, performance, and manufacturability considerations.

CMC Operations

• Manage external development and manufacturing partners (CDMOs), including vendor selection, oversight, and issue resolution.
• Drive the CMC components of regulatory submissions and agency interactions (e.g., IND, CTA, BLA).
• Develop and manage CMC timelines and budgets in alignment with clinical and corporate milestones.

Quality & Compliance

• Establish and maintain quality systems appropriate to stage of development, including support for GMP readiness.
• Support vendor audits, quality risk assessments, and compliance monitoring activities.
• Maintain CMC documentation and data packages suitable for regulatory submissions, due diligence, and partnership discussions.

Qualifications

• Ph.D., M.S., or B.S. in chemistry, pharmaceutical sciences, chemical engineering, or a related field.
• 12+ years of relevant industry experience in CMC, including leadership in clinical-stage development.
• Deep experience managing CDMOs and overseeing GMP manufacturing for both drug substance and drug product.
• Demonstrated expertise in formulation, process development, and regulatory strategy.
• Strong project management and communication skills, with comfort working cross-functionally in a lean and fast-moving biotech environment.