Director, Drug Product Development
Company: Formation Bio
Location: New York City
Posted on: January 27, 2026
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Job Description:
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.
Keywords: Formation Bio, Bayonne , Director, Drug Product Development, Science, Research & Development , New York City, New Jersey
