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Lead of Clinical Manufacturing and Control – CMC (m/f/d)

Full Time
Massachusetts, San Diego, US
Posted 2 months ago

Lead of Clinical Manufacturing and Control (m/f/d)

ATAI is a Berlin, New York, and London based biotech company builder leveraging a decentralized, data-driven platform model with the aim of ultimately healing mental health disorders. We are dedicated to bringing innovation to mental healthcare, a field that has seen little progress since the development of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) in the 1980s and 1990s, respectively.

From a drug development perspective, ATAI sees significant potential in 5HT2A agonists, atypical opioids, as well as drugs that act on the glutamatergic and GABAergic systems. In contrast to traditional neuropsychiatric drug development, we cultivate early-stage polypharmacological drugs that impact key mental health biomarkers and have been de-risked, either by anecdotal evidence or off-label clinical use.

We now have eight companies in our portfolio developing innovative solutions in mental healthcare, including COMPASS Pathways (psilocybin for treatment-resistant depression), DemeRx (ibogaine for opioid use disorder), and EntheogeniX (leveraging AI and computational biophysics to develop the next generation of psychedelics).

The Lead of CMC is responsible for overseeing both the strategic and operational aspects for all small molecule pharmaceutical development within ATAI and its subsidiary organizations, including oversight of drug discovery efforts and development and manufacturing of drug substance and drug product to support preclinical development and clinical trial activities.  In addition, this position will be responsible for general CMC due diligence in the context of business development activities. 

Employment type: full-time
Location: remote, preferably San Diego or MA

Opportunity

  • Be a major contributor to the success of a well-positioned, well-financed, rapidly growing biotech platform
  • Become part of an unparalleled effort towards developing and commercializing paradigm-shifting treatments in the mental health space
  • Work on improving the lives of millions of people with a real unmet need
  • Experience an open, and transparent start-up culture with a clear focus on execution and results
  • Shape and grow a new business within ATAI

Responsibilities

  • Overall responsibility for managing all drug substance and drug product activities and budgets transitioning from preclinical development to clinical development through clinical trial material supplies for clinical phase studies
  • Develop and implement a strategy for the identification, selection, and management of Contract Development Manufacturing Organizations (CDMOs) for process/formulation development, cGMP manufacture, and supply of Clinical trial materials (CTMs) for clinical development programs.
  • Formulation design/development to support clinical programs.
  • Direct efforts to implement phase appropriate analytical methods development and validations to ensure CDMOs are using systems and processes in compliance with all relevant regulatory standards.
  • Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization), and FDA regulations.
  • Direct the writing and reviewing documents for INDs and other regulatory section submissions; represent the company as the CMC expert before the U.S. and other regulatory authorities.
  • Work collaboratively within a multi-disciplinary environment, both within ATAI and the subsidiary organizations and with external consultants and CRO teams.
  • Work closely with the CSO and CMO to build and lead an interdisciplinary research program by collaborating on establishing scientific strategies, defining research goals and execution of new research projects
  • Contribute to the production of project-related documents, budgets, presentations, patents and regulatory submissions as required.

Qualifications

  • A Ph.D. with 10+ years of experience in the pharmaceutical industry
  • At least 5 years of experience in a leadership role and demonstrated leadership skills to serve as a change agent to identify needs and solutions, implement and support the building of a scientific organization is required.
  • You have a thorough knowledge and understanding of the relevant FDA and EMA regulations
  • You have experience with managing external manufacturing organizations in a virtual setting 
  • You have a strong track record in leading cross-functional teams in advancing projects
  • You are a creative, analytical problem solver, who acts decisively, yet communicates the risks and benefits associated with all potential solutions so that informed business decisions can be made
  • You are highly empathetic with an outstanding ability to work multi-culturally
  • You are willing to work in a challenging, fast-paced environment and to adapt to new situations as they arise
  •  You have excellent communication and presentation skills, as you will frequently communicate with the C-Level of ATAI, the platform companies and the board
  • You effectively delegate responsibility and authority

How to apply

Join us to improve the lives of millions suffering from a real unmet medical need – apply today via the apply button on the right and send us your updated CV, your degree certificates, and references. 

Please note that we can only accept applications from people that have a valid EU work permit.

If you have any questions, don’t hesitate to call or write us:

Juliane Schmidt
Human Resource Manager
careers@atai.life

Job Features

Job CategoryClinical
Apply by clicking the button above.
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