Director, Formulation Development

Formation Bio•New York, NY

2d•$242,000 - $290,000•Hybrid

About The Position

Formation Bio is seeking a motivated, experienced Director, Formulation Development to join our dynamic team. This critical role will report to the VP, CMC and will be responsible for leading formulation development and manufacture for all drug candidates on the Formation Bio pipeline. This role requires a blend of technical expertise, strategic thinking, leadership capabilities, and a strong regulatory and industry knowledge base in pharmaceutical sciences or engineering to drive successful drug product development and manufacturing operations.

Requirements

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

Nice To Haves

Experience of enabled formulation development (spray drying, HME) to support preclinical to early development programs
Experience in development of other dosage forms and combination products.
Solid state characterization and pre-formulation development experience.
Understanding of biopharmaceutical fundamentals

Responsibilities

Technical Leadership: Provide technical leadership for development and manufacturing of phase appropriate formulations for Formation Bio programs. (pre-IND to Phase 2/3) This is primarily focused on development of solid oral dosage forms, but could include solid state characterization, pre-formulation and alternate dosage forms, as well as the development of formulations for injection.
Cross-Functional Collaboration: Partner with other CMC groups (analytical development, supply chain, etc) quality assurance, regulatory, clinical pharmacology and project management to support short and long term program objectives.
CRO and CDMO Management: Oversee and manage drug product vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards.
Documentation: Author and review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations.
Regulatory submissions: Author, and contribute to regulatory submissions, including INDs, BLAs, and other regulatory dossiers.
Due-Diligence Support: As part of Formation Bio’s strategy to in-license programs and develop to point of inflection, support the Business Development Team with assessment of potential new assets from a technical and financial risk standpoint.