CMC Associate

Who we are:

atai Life Sciences is a biopharmaceutical company focused on developing novel treatments (both psychedelic and non-psychedelic) for mental health disorders so that everyone, everywhere can live a more fulfilled life. We are developing psychedelic and non-psychedelic compounds and cutting-edge digital therapeutic tools. We are excited about anything that might mean a true leap forward for patients. We have offices in Berlin, London, New York, Boston, and San Diego (and our office culture is important to us). Check out our website here.

The CMC team at atai Life Sciences delivers robust, scalable, and cost-effective drug substance and drug product manufacturing processes and products to enable clinical drug development.

What is the role (purpose)

As CMC Associate, you will work together with the CMC team and other cross functions to enable and support all CMC activities for seamless execution of projects/programs.

What you will achieve:

The role will take on the following responsibilities:

Manage CMC Contracts

  • Initiate and manage contract workflows on ironclad (CDA, MSA, SOW, CO, QTA), working closely with the legal team to get contracts to completion.
  • Maintain an archive and overview of all executed, in-process and upcoming contracts

Data Files & Access Management

  • File and maintain all CMC documents on the internal SharePoint (contracts, audit reports, working drafts, RFPs, IDSs, etc…)
  • Act as point person to manage access to the site
  • Onboard members of the team to SharePoint
  • Set up Power Automate workflows to manage user notifications

Compound Inventory Management

  • Work closely with the CMC Manager and partner lines to plan future drug supply needs for preclinical and clinical programs in compliance with the associated budgets and timelines
  • Maintain and file CoAs of the compounds on SharePoint to make them readily accessible

CMC Budget & Accounting

  • Support the CMC team in budgetary discussions and help create budgets
  • Work with the Finance & Operations team to initiate POs and share with vendors
  • Maintain an overview of SOWs and statuses
  • Review and approve POs and invoices on a regular basis
  • Coordinate unpaid/delayed invoices 

Vendor Management & Set up

  • Support with identification, selection, and management of Contract Development and Manufacturing Organizations (CDMOs)
  • Support vendor and customer set up forms
  • Create SharePoint sites and folder structures for vendors
  • Liaise with the vendor to set up and enable seamless data sharing
  • Act as point person to manage access to the site
  • Set up and manage Power Automate workflows

Manage subscriptions

  • Coordinate and facilitate subscriptions for the CMC team members
  • Manage access to subscribed resources for common to R&D members

Over the first three months, the following staged goals are envisaged for the role:

  • Within the first 1-2 weeks, come up to speed with Ironclad and take over contracts handling activities, working with our lawyers, and liaising with external parties.
  • Within the first 30 days, understand how the CMC SharePoint is set up and start managing all CMC files on SharePoint.
  • Within the first 60 days, come up to speed with the programs that the CMC team spends most of their focus on and become familiar with the compound inventory system to support filing and linking documents to it (e.g., CoAs)
  • Within the first 90 days, be fully onboarded on CMC programs and all the remaining tasks associated with the role of independent working

Measurable success in a year is when the associate can deliver all the tasks assigned to the role independently and all CMC activities are running smoothly (i.e., no noticeable delays in contracts because of hold up on the CMC side, or all documents are kept up to date on SP and are easy to find and so on)

Who will be successful in this role:

A successful candidate with a Degree in Science, preferably focused on Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology, or equivalent will possess:

  • Sharp planning, organizational, and multitasking skills
  • A high level of computer literacy or prior hands-on experience with business-related software (SharePoint, Microsoft Office, Ironclad, NetSuite)
  • Prior experience in Biotech or knowledge of drug development process and/or familiarity with CMC terminologies is a major plus
  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects
  • Fluent English (oral and written) skills
  • Knowledge of basics of accounting (desirable)

To succeed in this role, it is also important that you are self-motivated, detail-oriented, can work to deadlines, are a quick learner, and can work independently in collaboration with others.

 For Everyone, Everywhere

Team Photo

 

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