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Director of Formulation Development (f/m/d)

ATAI Life Sciences

ATAI Life Sciences

Delaware, USA · United States
Posted on Thursday, August 3, 2023

Location: DE or UK

The Director of Formulation Development at atai Life Sciences serves as a critical expert in advancing the company's mission to develop novel treatments for mental health disorders. They are primarily responsible for driving the formulation development of atai’s drug assets, optimizing process understanding, troubleshooting formulation challenges, and ensuring compliance with regulatory requirements, thereby facilitating the transition of new compounds from bench to bedside.

atai's Research Chapter focuses on the discovery of new molecules, translational research, non-clinical development, and early clinical development, bringing the saying ‘from bench to beside’ to life.

Who we are:

atai Life Sciences is a biopharmaceutical company focused on developing novel treatments for mental health disorders so that everyone, everywhere, can live a more fulfilled life. To achieve this, we are developing psychedelic and non-psychedelic compounds and cutting-edge digital therapeutic tools, and we are excited about anything that might mean a true leap forward for our patients. We operate a hybrid virtual/in-person working model, with most of the team spending 2-3 days in the office, and our hubs are located in Berlin, New York City, and San Diego.

What you will achieve:

Within your first month, familiarize yourself with atai's current drug assets; During your first 3 months, guide the development and optimization of the drug product formulation strategy for at least one of atai's key drug assets; By the end of your 6 months, contribute to atai's patent portfolio through the development of innovative compositions of matter formulations.

The specifics of your day-to-day will include:

  • Develop phase-appropriate drug product formulation strategy to enable early clinical trials and build toward later clinical phases and commercial in compliance with regulatory requirements
  • Oversee execution of formulation development and optimization and process understanding at CDMOs through rational experimental design, thoughtful and thorough data interpretation, with emphasis on statistical analysis
  • Review and approve batch records, drug products specifications, stability protocols, source documents, and technical reports
  • Work with cross-functional peers and CDMOs to enable timely delivery of clinical testing material and plan for registration and validation/commercial batches
  • Troubleshoot and resolve high-complexity formulation challenges
  • Author and review regulatory filings and responses to agencies' information requests
  • Contribute to atai patents portfolio through innovative composition of matter formulations
  • Communicate progress cross-functionally and to management
  • Draft requests for proposals and review service agreements and work proposals
  • Collaborate with business operations function on the selection of CDMOs for late clinical phases and commercial

Qualifications / experience that we'd like to see:

  • Ph.D. in Pharmaceutics or equivalent with 10 years of industrial experience, or Master’s in one of these disciplines with 15 years of industry experience
  • Strong expertise and demonstrated experience in the development of successful transmucosal formulations for buccal application
  • Thorough understanding of drug metabolism, pharmacokinetics, and biopharmaceutical modeling to enable formulation of specific solid oral dosage forms (delayed-release, extended-release solid dosage forms) and dosing regimen to reduce pill burden
  • Strong expertise and demonstrated experience in the development of successful parenteral formulations for IV, sub Q or IM routes of administration, as well as intranasal formulations
  • Team player capable of seamlessly working across various R&D and G&A functions
  • Excellent verbal and written communications skills
  • Prior hands-on experience with IND, IMPD, NDA, MAA

Who will be successful in this role:

Those who succeed at atai will be strongly aligned with our values:

  • ❤️ Conscious Care: We take every action in service of our ultimate goal: to heal mental health disorders for all while caring for ourselves and our team.
  • 🦸 Bold Entrepreneurship: We are “loosely coupled but tightly aligned” as we strive for excellence over perfection, fast and focused to accelerate innovation for patients.
  • 🧑‍🤝‍🧑 Collaborative Innovation: individuals and teams work together with good humor and no drama, valuing different perspectives and diversity of thought, background, nationality, and style.
  • Radical Responsibility: We take full responsibility for our circumstances. We grow and learn from failures, always looking to improve.

At atai, we value diversity of thought, background, and experience. We encourage applications from everyone everywhere – especially women, people of color, and members of the LGBTQIA+ community.

Research shows that members of minority groups are less likely to apply for a job unless they believe they meet all the requirements listed. Even if you feel that you do not meet 100% of the job criteria, we’d love to hear from you.

You might be a great fit for another position now, or in the future. We look forward to hearing from you!

Check out the video below to learn more about why we do what we do!

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