About Formation Bio

At Formation Bio, we are building the next generation of pharmaceutical company—redefining drug development with our proprietary, technology-driven platform. Our mission is to deliver new treatments to patients faster and more efficiently.

Formation Bio licenses clinical-stage drug candidates and develops them in-house using our advanced, technology-led platform. In recent years, we have accelerated drug development substantially, with the ability to speed up more than 300 clinical trials and reduce trial timelines by up to 50%. This translates into bringing life-saving medicines to market 1–3 years earlier. We focus on partnering with—and growing—in-house clinical-stage programs, supported by a team of specialists from across multiple industries that combines top talent in both technology and pharma.

Join a culture of innovation where your work directly supports better patient care in areas such as rheumatology, dermatology, the CNS, and cardiometabolic diseases. Our fast-moving environment blends advanced technology with strategic drug development to accelerate the delivery of new therapies. Every role contributes to our goal of getting new treatments to patients sooner and more effectively.

About the Role

As the Director of Analytical Development and QC, you will lead the strategy and execution of analytical research and development and quality control activities for active pharmaceutical ingredients (API) and drug product (DP) at Formation Bio and our contract R&D and manufacturing partners for assets in Phase 1 through Phase 3. You will manage all API and DP release stability testing and oversee analytical regulatory documentation supporting global clinical studies. This position is critical to ensuring alignment with regulatory requirements and company goals. Success in this role requires technical expertise, strategic judgment, leadership skills, and a strong foundation in regulatory affairs.

Responsibilities

• Provide technical leadership and direction across CMC development activities for all outsourced analytical methods and testing by setting clear goals for multiple CDMO partners.

• Oversee the creation of testing methodology specifications and stability programs for raw materials, intermediates, excipients, APIs, and DPs, including trend analysis and retesting strategies for clinical trial materials.

• Develop budgets and forecasts for drug substance and drug product analytical development, including costs involving CMOs and consultants.

• Mentor and support internal and external team members, promoting professional growth while ensuring project success and achievement of expected outcomes. Assess performance, provide feedback, coach team members, and build strong cross-functional teams. Mentor them on all aspects of drug product development and manufacturing.

• Define project deliverables, take ownership, and ensure accountability to internal stakeholders. Partner with the wider team to achieve established objectives.

• Author, review, and contribute strategically to regulatory submissions (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers).

• Work closely with Quality Control and Regulatory teams to support the selection of strategic CDMO, manufacturing, analytical, and packaging partners.

• Build and maintain strategic relationships with CMOs, suppliers, and consultants, providing oversight and recommendations for collaborations.

• Strengthen cross-functional relationships to translate research and clinical program objectives into clear, aligned, and fit-for-purpose CMC goals and milestones.

• Author and review technical documents while staying current with industry trends, regulations, and best practices. Drive implementation of innovative technologies and quality-by-design (QbD) approaches.

• Review and approve analytical methods, specifications, change controls, deviations, investigations, out-of-trend, and out-of-specification reports.

• Collaborate closely with other members of the CMC team supporting API and DP development and assist management as needed.

• Partner with Drug Substance and Drug Product colleagues, as well as QA, in selecting CDMO partners across all development stages.

• Develop strong relationships with external partners to define and manage scopes of work, ensuring all activities meet program expectations.

• Coordinate with Regulatory, QA, and Senior Management to ensure company policies are followed and that all external manufacturing work complies with applicable regulations.

• Create new systems/SOPs/policies and work with Quality Assurance to ensure compliance with current GXP requirements.

• Deliver presentations and progress reports to leadership as needed for multi-disciplinary development teams.

About You

• PhD in analytical chemistry or a related field, with at least 15 years of analytical/CMC leadership experience in the CDMO, biotechnology, or pharmaceutical industry.

• Experience working with Contract Research Organizations and/or managing relationships with contract laboratories.

• Strong technical background in analytical development and validation for APIs and DPs, characterization, and stability across a range of formulations, including solid oral dose, dermal, and injectable products.

• Expertise in reviewing and interpreting release and stability data for trending, shelf-life, and specification-setting. Thorough understanding of phase-appropriate method qualification and/or validation and specifications for APIs and DPs.

• Experience in manufacturing and a solid understanding of cGMP requirements.

• Ability to write RFPs, protocols, reports, and regulatory documents.

• Outstanding interpersonal, negotiation, problem-solving, communication, and analytical skills.

• Leadership strengths including emotional intelligence, strategic thinking, mentorship, and a commitment to continuous improvement.

• Comprehensive knowledge of ICH, FDA, and EMA guidance and GMP requirements related to product/process development, manufacturing, and stability.

• Excellent interpersonal skills, including negotiation abilities and a tactful style that results in strong service value and successful outcomes.

• Exceptional risk management, problem-solving, and crisis management capabilities.

• Ability to work effectively in cross-functional drug development teams.

• Highly organized, proactive, and detail-oriented.

• Proven leadership and management experience, including prior work directing others and collaborating with internal teams and external partners across multiple CMC programs.

• Up-to-date knowledge of the latest technologies, trends, and practices in analytical development, manufacturing, and outsourcing.

Travel

Travel may be required up to 25–30% of the time.

We offer competitive compensation to attract and reward the best people for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In accordance with NYC’s pay transparency law and to support pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this position is $240,000–$280,000.

In addition to base salary, we offer equity, generous benefits, flexibility in where you work, and a comprehensive benefits package—learn more here about our compensation philosophy and perks.

If this range doesn’t match your expectations, please still apply—we may have other opportunities that could be a better fit.

We consider candidates for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.