The Director of Process Chemistry will be a critical member and decision maker reporting to the Vice President of CMC. The scope of the position runs from process design and development through manufacturing and regulatory submission.

Responsibilities include, but are not limited to:

  • Develops an overall API strategy including timelines, budgets, risk & mitigation plans for all API process development and manufacturing campaigns
  • Directs synthetic route scouting and optimization to design phase-appropriate synthetic routes and implement regulatory control strategies for GMP manufacturing
  • Reviews, authors, and approves manufacturing process documentation such as process development protocols and reports, batch records, validation protocols and reports, specifications, etc.
  • Manages external CRO/CDMO activities to achieve on-time delivery of non-GMP and GMP materials from gram scale to multi-kilogram quantities
  • Oversees technical solutions to ensure that API processes are successfully demonstrated and delivered
  • Leads selection and sourcing of starting materials for API and the setting of API specifications
  • Leads selection of API CDMO manufacturers
  • Oversees characterization of physical properties and selection of API form including polymorph and salt screening studies, crystallization, and crystal engineering, in collaboration with CMC team
  • Directs the identification, preparation and characterization of impurities and degradation products
  • Evaluates and approves external work orders related to API process development and manufacturing
  • Authors appropriate CMC sections to support regulatory (IND, IMPD, etc.) submissions
  • Partners with various functions in the company (Chemistry, Quality, Regulatory, Pharmaceutics, Clinical Development, Project Management, Business Development, Materials Management) to maximize productivity in all responsibilities
  • Evaluates and proposes improvements to process chemistry operations at ATAI
  • Writes experimental protocols, technical, and development reports capturing details of experiments conducted and conclusions drawn
  • Writes progress reports and gives presentations at various meetings
  • Maintains a command of new scientific literature and regulatory/quality requirements for pharmaceutical products and evaluates implications for company programs
  • Other related duties as assigned

Requirements:

  • PhD in Chemistry with at least 10 years of industry experience in process chemistry in the biotechnology/pharmaceutical industry
  • A high level of expertise in all areas of process chemistry, in depth knowledge of the principles and practices of pharmaceutical science, and mastery of emerging, innovative technologies
  • Direct hands-on experience in process chemistry research and development
  • Solid state, crystallization and crystal engineering experience is a plus.
  • At least 3 years’ experience in a leadership position
  • Previous experience managing projects at CROs/CMOs
  • Extensive experience with drug development and broad knowledge of regulatory and quality requirements for pharmaceutical products
  • Experience with authoring regulatory documents for IND and NDA filings for new chemical entities
  • A strong track record of accomplishments in developing and implementing robust and efficient drug substance manufacturing processes
  • Experience working in a GMP environment and previous regulatory submissions would be a plus
  • Excellent interpersonal, verbal, and written communication skills
  • Effective troubleshooting and problem-solving skills
  • Comfortable in a fast-paced small company that requires flexibility to adjusting workloads based upon changing priorities and willingness to be a team player to accomplish project goals regardless of level or type of work

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