Description
Location: Boston/Cambridge Area
Stage: Seed
About Gaia:
Gaia Health is an early stage consumer biotech company focused on developing advanced controlled release drug delivery technologies through the lens of patient trust, design, and experience. Our platform enables new therapies to reach patients and makes existing ones more precise, accessible, and easier to live with. Working alongside patients, clinicians, and innovators, we’re unlocking the full potential of modern medicine. Backed by world class angel and institutional investors, and supported by advisors and industry veterans at the intersection of pharma, consumer products, and healthcare, we are building with ambition and purpose.
The Role:
We’re seeking a Director or Senior Director of Formulation to lead development of complex, differentiated drug products as our programs advance toward the clinic and commercialization. This is a hands-on leadership role for someone who thrives in ambiguity, applies first principles across new modalities, and enjoys building where the playbook doesn’t yet exist.
You will own formulation strategy and execution end to end. Driving development planning, CRO/CDMO oversight, and CMC readiness using Quality by Design principles and rigorous, data driven experimentation. Your work will directly shape our technical direction, manufacturing strategy, and the therapies we ultimately deliver to patients.
Key Responsibilities:
- Lead formulation and drug product development for complex dosage forms
- Implement QbD, define CQAs/CPPs, and build robust regulatory ready data packages
- Design and interpret DoE studies to guide product and process development
- Manage CRO/CDMO partners and oversee external development/manufacturing
- Create the roadmap to IND, clinical development, and commercialization
- Rapidly establish commercial readiness for multiple products, including scale up strategy, manufacturing approach, and launch enabling CMC planning
- Collaborate with engineers to design custom equipment and processes
- Contribute to CMC strategy and author sections of INDs/NDAs
- Ensure cGMP compliance and risk based quality planning
- Jump into the lab or travel to CROs/CDMOs when needed
Required Qualifications:
- Ph.D. with 10+ years of relevant experience, or M.S./B.S. with commensurate industry experience demonstrating equivalent technical depth and leadership
- Hands on experience with advanced manufacturing operations such as hot melt extrusion, injection molding, or other complex dosage form technologies
- Expertise in non-oral routes of administration and a strong understanding of how physicochemical properties influence drug product performance
- Proven ability to apply QbD principles, define CQAs/CPPs, and build regulatory ready data packages
- Significant experience using DoE and modeling to drive product and process understanding
- Proven track record managing CRO/CDMO partners, including late stage development and tech transfer
- Strong understanding of cGMP, stage appropriate quality strategies, and risk based planning
- Experience authoring CMC sections of IND, NDA, or equivalent regulatory submissions
- Experience working with highly potent compounds, including safety, containment, and operational considerations
- Demonstrated ability to solve unconventional technical challenges, learn quickly, and apply core principles across new modalities
- Collaborative, low ego leadership with strong communication and team building skills
Preferred Qualifications:
- Experience leading development and commercial launch of at least one drug product or combination product
- Experience designing custom equipment or novel manufacturing systems
- Background in novel drug delivery technologies or cutting edge materials/platforms
- Early stage startup experience, or clear evidence of thriving in ambiguous, fast moving environments
- A record of thought leadership (patents, publications, conference talks, recognized innovation)
Who You Are:
- A creative problem solver who thrives when the answer isn’t in a handbook
- A scientifically rigorous thinker who loves designing experiments that reveal insight, not just generate data
- A builder eager to help shape the culture, systems, and long term capabilities of a growing company
- Someone who leads with empathy, humility, curiosity, and a collaborative spirit
- Energized by challenges and driven to improve the quality of life for patients
- An ambitious leader who wants to be part of something transformative
Why Join Us:
- Contribute to a fundamental shift in how we relate to medicine and create a world class product that touches billions of lives.
- The opportunity to help develop revolutionary drug delivery technologies that lead to far better patient outcomes and quality of life.
- Working alongside a world class internal team as well as our external advisors, clinicians, and investors.
- Join early with a competitive salary, meaningful equity, and full health benefits
- A culture that values creativity, inclusivity, kindness, and a shared mission to make the world healthier.
- A dynamic role that evolves with the company, offering flexibility to take on new challenges in areas of high impact.
Requirements
Required Qualifications:
- Ph.D. with 10+ years of relevant experience, or M.S./B.S. with commensurate industry experience demonstrating equivalent technical depth and leadership
- Hands on experience with advanced manufacturing operations such as hot melt extrusion, injection molding, or other complex dosage form technologies
- Expertise in non-oral routes of administration and a strong understanding of how physicochemical properties influence drug product performance
- Proven ability to apply QbD principles, define CQAs/CPPs, and build regulatory ready data packages
- Significant experience using DoE and modeling to drive product and process understanding
- Proven track record managing CRO/CDMO partners, including late stage development and tech transfer
- Strong understanding of cGMP, stage appropriate quality strategies, and risk based planning
- Experience authoring CMC sections of IND, NDA, or equivalent regulatory submissions
- Experience working with highly potent compounds, including safety, containment, and operational considerations
- Demonstrated ability to solve unconventional technical challenges, learn quickly, and apply core principles across new modalities
- Collaborative, low ego leadership with strong communication and team building skills
Preferred Qualifications:
- Experience leading development and commercial launch of at least one drug product or combination product
- Experience designing custom equipment or novel manufacturing systems
- Background in novel drug delivery technologies or cutting edge materials/platforms
- Early stage startup experience, or clear evidence of thriving in ambiguous, fast moving environments
- A record of thought leadership (patents, publications, conference talks, recognized innovation)
