NorthLinks Bio- Director/Senior Director CMC

About Raven:
We are Raven, RA Capital’s healthcare incubator. From discovery to delivery, whether we incubate, accelerate or rejuvenate, Raven’s goal is to turn scientific breakthroughs into transformative therapies and get them quickly, safely and efficiently to the patients that need them most. Raven’s experienced scientists, operators, and healthcare innovators have deep sector expertise across therapeutics, diagnostics, devices and services. They have brought hundreds of therapeutics into development, managed hospital systems, optimized clinical trials and navigated payor and regulatory systems to deliver patient impact - and they are ready to work with you.

About RA Capital:
Founded in 2004, RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital creates and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization and beyond. RA Capital's knowledge engine is guided by our Tech Atlas internal research division, and Raven, RA Capital’s company building team, offers entrepreneurs and innovators a collaborative and comprehensive platform to explore the novel and the re-imagined. RA Capital has more than 150 employees and over $10 billion in assets under management.

About NorthLinks Bio

NorthLinks Bio is a clinical-stage biotechnology company advancing novel therapeutics with broad potential across respiratory and infectious diseases. Led by RA Ventures, NorthLink Bio operates with a focused, execution-driven team and is progressing a differentiated antiviral program through early 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.

• Familiarity with intranasal, inhaled, or other complex drug–device delivery platforms is a strong plus.

• 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—$280,000 USD