Director, Process Chemistry

Apply Now

At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.

Summary:

Reporting to the Vice President, Process Chemistry, the Director, Process Chemistry oversees the Global Supply Chain for sourcing of drug substance (API) for DICE’s development programs and will be responsible for all API PR&D, process optimization and manufacturing activities.

Responsibilities:

  • Manages technology transfer, process familiarization and drug substance manufacturing at CDMOs in compliance with cGMP.
  • Develops global manufacturing strategy by identifying and selecting appropriate vendors for raw materials, intermediates and APIs with a focus on meeting aggressive timelines.
  • Assists with the selection of synthetic routes, identification of regulatory starting materials, development of synthetic processes with focus on API quality, supply chain security and COG reduction strategies.
  • Liaises with Analytical Development to ensure API’s are well characterized and adequately controlled from a QC perspective.
  • Liaises with Formulation Development to identify key physico-chemical properties and ensure they are controlled for adequate product development.
  • Provides technical support and input to internal groups regarding processes, and API quality requirements.
  • Plays a critical role as the API lead on internal project teams to provide assessments, evaluations, status, issues and other relevant technical aspects of the corresponding program.
  • Works closely with Legal function for the execution of NDAs, Service and Supply Agreements and Intellectual Property strategies.
  • Oversees the flow of the organization’s products through production, including the planning of production schedules, coordinating materials requirements, and formulating and recommending manufacturing policies and programs.
  • Reviews all manufacturing proposals, updates and reports.
  • Provides leadership and leads development efforts at CDMOs through regular communications and project meetings.
  • Review Master Batch Records (pre-execution) and ensure they are GMP compliant and address all aspects of a defined process.
  • Assists with writing of regulatory documents to support regulatory filings.
  • Travels for kickoff meetings, audits, on-site meetings and man in plant exercises.
  • Review Batch Records post-execution.
  • Other related duties as assigned.

Qualifications and Requirements:

  • PhD in Chemistry or other related field and 12 years of directly related experience, or the equivalent combination of education and experience.
  • Minimum 10 years-experience overseeing CMC Manufacturing activities.
  • Previous experience overseeing global supply chain.
  • Good problem solving, decision making, leadership and communication skills.
  • Ability to work independently and as a functional leader and participant in teams.
  • Strong written and oral communication skills.
  • Experience in authoring CMC sections for regulatory submissions.
  • Experience in negotiating Commercial Supply Agreements.
  • Experience overseeing and coordinating CMO’s with a focus on North America, Europe and Asia.

Salary Range 190,000 213,000

The pay range for this position that we reasonably expect to pay. Individual compensation is based on various factors including, experience, education, skillset, and geographic location. This range is for the Bay Area, California location and may be adjusted to the labor market in other geographic areas.

DISCLAIMER

The above information in this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Apply Now