Director, Drug Product Development

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.

You can read more at the following links:

• Our Vision for AI in Pharma
• Our Current Drug Portfolio
• Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

About the Position

Formation Bio is seeking a motivated, experienced Director, Drug Product 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.

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.

About You

Required Qualifications

• 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.

Preferred Qualifications

• 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

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

Compensation:

The target salary range for this role is: $242,000-$290,000

Salary ranges are informed by a number of factors including geographic location. The range provided includes base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you.

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