BioSpace
Director, Formulation Development – Formation Bio
We are seeking an experienced Director of Formulation Development to join our dynamic team at Formation Bio, a tech and AI-driven pharma company founded in 2016 that accelerates drug development and clinical trials using advanced technology platforms.
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 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.
Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform
About the Position This role reports to the VP, CMC and will lead formulation development and manufacture for all drug candidates on the Formation Bio pipeline. It requires a blend of technical expertise, strategic thinking, leadership capabilities, and strong regulatory and industry knowledge in pharmaceutical sciences or engineering.
Responsibilities
Provide technical leadership for development and manufacturing of phase appropriate formulations for Formation Bio programs (pre-IND to Phase 2/3), primarily solid oral dosage forms with potential solid state characterization, pre-formulation, alternate dosage forms, and injection formulations.
Partner with other CMC groups (analytical development, supply chain, quality assurance, regulatory, clinical pharmacology, and project management) to support short- and long-term program objectives.
Oversee and manage drug product vendors (CROs/CDMOs) for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards.
Author and review technical documents with Quality colleagues to assure compliance with current GxP regulations.
Author, and contribute to regulatory submissions, including INDs, BLAs, and other regulatory dossiers.
Support the Business Development Team with assessment of potential new assets from a technical and financial risk standpoint.
Qualifications Required Qualifications
MS or PhD in pharmaceutical sciences, chemical engineering, organic chemistry, or related discipline.
Minimum of 10 years’ technical experience in formulation development and manufacturing in the pharmaceutical/biotech industry.
Experience with development and manufacturing of solid oral dosage forms for small molecule programs.
Demonstrated experience 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 with 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.
Location and work model: Primarily headquartered in the New York City and Boston metro areas, with a hybrid work model requiring 1-3 days in 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, inclusive of base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more.
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.
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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 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.
Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform
About the Position This role reports to the VP, CMC and will lead formulation development and manufacture for all drug candidates on the Formation Bio pipeline. It requires a blend of technical expertise, strategic thinking, leadership capabilities, and strong regulatory and industry knowledge in pharmaceutical sciences or engineering.
Responsibilities
Provide technical leadership for development and manufacturing of phase appropriate formulations for Formation Bio programs (pre-IND to Phase 2/3), primarily solid oral dosage forms with potential solid state characterization, pre-formulation, alternate dosage forms, and injection formulations.
Partner with other CMC groups (analytical development, supply chain, quality assurance, regulatory, clinical pharmacology, and project management) to support short- and long-term program objectives.
Oversee and manage drug product vendors (CROs/CDMOs) for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards.
Author and review technical documents with Quality colleagues to assure compliance with current GxP regulations.
Author, and contribute to regulatory submissions, including INDs, BLAs, and other regulatory dossiers.
Support the Business Development Team with assessment of potential new assets from a technical and financial risk standpoint.
Qualifications Required Qualifications
MS or PhD in pharmaceutical sciences, chemical engineering, organic chemistry, or related discipline.
Minimum of 10 years’ technical experience in formulation development and manufacturing in the pharmaceutical/biotech industry.
Experience with development and manufacturing of solid oral dosage forms for small molecule programs.
Demonstrated experience 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 with 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.
Location and work model: Primarily headquartered in the New York City and Boston metro areas, with a hybrid work model requiring 1-3 days in 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, inclusive of base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more.
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.
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