RA Capital

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.

The base salary range reflects our good faith estimate at the time of posting. Final compensation will depend on factors like experience, skills, and location. The role may also be eligible for an annual bonus and long-term incentives. Compensation and benefits may be updated in the future.

Salary base range

$210,000 - $290,000 USD