Director, Formulation Development

Director, Formulation Development

Formation Bio

Formation Bio is a tech and AI‑driven pharma company founded in 2016 as Trial Spark Inc. We build technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Our mission is to help bring new medicines to patients faster and more efficiently by partnering, acquiring, or in‑licensing drugs from pharma companies, research organizations, and biotechs.

Formation Bio seeks a motivated and experienced Director of Formulation Development to lead formulation development and manufacture for all drug candidates on the pipeline. This role reports to the VP of CMC and requires technical expertise, strategic thinking, leadership, and strong regulatory knowledge in pharmaceutical sciences.

• Provide technical leadership for development and manufacturing of phase‑appropriate formulations (pre‑IND to Phase 2/3), primarily solid oral dosage forms with possible alternate dosage forms.
• Partner with cross‑functional teams (analytical development, supply chain, quality assurance, regulatory, clinical pharmacology, project management) to support program objectives.
• Oversee and manage drug product vendors (CROs/CDMOs) ensuring GMP compliance and high‑quality deliverables.
• Author and review technical documents in collaboration with Quality to assure GxP compliance.
• Contribute to regulatory submissions, including INDs, BLAs, and other dossiers.
• Support business development by assessing potential new assets from a technical and financial risk standpoint.

We are looking for individuals with a strong background in formulation development and manufacturing.

• MS or PhD in pharmaceutical sciences, chemical engineering, organic chemistry, or a related discipline.
• Minimum of 10 years’ technical experience in formulation development and manufacturing within the pharmaceutical/biotech industry.
• Experience with solid oral dosage forms for small‑molecule programs.
• Experience selecting and collaborating with domestic and international CROs/CDMOs and consultants.
• Manufacturing experience and a good understanding of cGMP requirements.
• Proficiency in writing RFPs, protocols, reports, and regulatory documents.
• Ability to travel domestically and internationally up to 25% of the time.

• Experience in enabled formulation development (e.g., spray drying, HME) for preclinical to early‑development programs.
• Experience developing other dosage forms and combination products.
• Solid state characterization and pre‑formulation development experience.
• Understanding of biopharmaceutical fundamentals.

We prioritize hiring in major hubs, primarily the New York City and Boston metro areas. These positions will follow a hybrid work model with 1–3 days required in the office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.

Target salary range: $242,000–$290,000 (base only). We also offer equity, comprehensive benefits, generous perks, and hybrid.

We will consider your application even if the range does not match your expectations.

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

Director

Full‑time

Other