Full Time
Boston, New York City
Posted 1 month ago

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. We operate a decentralized model whereby atai incubates, acquires, and supports individual platform companies by providing them strategic and operational functions centrally. This allows our platform companies to stay lean and agile in their clinical pursuits, whilst also being able to leverage the expertise of a multibillion-dollar global biotechnology company. Atai is pursuing a world-first strategy by deploying our clinical compounds together with our ecosystem of Digital Therapeutics, utilizing cutting-edge technology, clinical protocol, human-interaction psychology, and data science in order to enhance the safety and efficacy of our compounds. 

The Associate Director, Formulation Development at atai Life Sciences, will be a key contributor in developing various drug products from exploratory development through various clinical phases in a Quality by Design (QbD) environment using lab based and computational tools.

What you’ll do at atai:

  • Apply thoughtful ideas and scientific rigor to understanding the relational effects of small molecule formulation design and deep process understanding to achieve desired bioperformance and deliver robust dosage forms and drug product manufacturing processes for clinical trials.
  • Deliver and oversee the optimization of formulation and process understanding through rational experimental design, thoughtful execution and clear data interpretation, with a heavy emphasis on statistical analysis
  • Direct, overview, and coordinate development and manufacturing activities at CDMOs and CMOs and nurture strong partnerships.
  • Work with CDMOs and CMOs to enable timely delivery of clinical testing material and plan for registration and future validation/commercial batches.
  • Review and approve batch records, products specifications, stability protocols, data, and reports.
  • Being accountable for troubleshooting and resolving high complexity formulation challenges.
  • Work in a multidisciplinary cross-functional environment
  • Develop strategy for regulatory submissions
  • Utilize and support the use of a mixture of computational models, small scale characterization tools, and knowledge-based guidance to efficiently develop formulations that have excellent bio performance and can be readily manufactured at the clinical and commercial scale
  • Author and review technical reports, regulatory filings and responses to deficiency letters, source documents, patents.
  • Overcome challenges of small molecules (poor water solubility, first-pass metabolism, instability, etc.) applying bioavailability enhancing techniques, selecting appropriate dosage forms in combination with administration routes, as well as solve processability and scalability challenges.

We believe you’ll be successful in this role if you are this type of person:

  • Highly empathetic with an outstanding ability to work multi-culturally
  • Willing to work in a challenging, fast-paced environment and to adapt to new situations as they arise
  • Collaborative and seek learning from team members
  • Proactive learner and endlessly curious, particularly about scientific knowledge
  • Thrive in challenging, fast-paced work environments
  • Adapt quickly to changing situations and new problems

These qualifications will get us excited to get to know you better:

  • PhD in Pharmaceutical Sciences and/or Chemical Engineering with 6-8 years of industrial experience.
  • OR Masters in one of these disciplines with 10-12 years industrial experience.
  • Prior experience with a variety of dosage forms and with drug/devices.
  • Proven track record of applying fundamental scientific principles to formulation design, development, and process optimization utilizing design of experiments
  • In depth knowledge of statistical analysis
  • Thorough knowledge of ICH, FDA and EMA guidance documents
  • Possess in depth knowledge and prior practice of domestic and European regulatory filings (IND, IMPD, NDA, MAA)
  • Excellent verbal and written communication
  • Ability to travel as needed to assigned atai Hub office location (New York, NY or Boston, Massachusetts, or SD, London, or Berlin) up to every two weeks (to be agreed in advance with manager)

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