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.
Reporting to the Senior Vice President, CMC, the Director/Senior Director, Process Chemistry oversees the global supply chain of drug substance and related starting materials and intermediates for DiCE’s development programs and will be responsible for API process research and development, process optimization and manufacturing activities.
· Design and oversee the selection of synthetic routes, define regulatory starting materials, develop synthetic processes with focus on API quality, supply chain security and cost reduction.
· Manage technology transfer, process familiarization and drug substance manufacturing at contract service providers (CSPs)in compliance with cGMP.
· Develop global manufacturing strategy by identifying and selecting appropriate vendors for raw materials, intermediates, and APIs to meet aggressive timelines.
· Work with Analytical Development to ensure active ingredients, intermediates and raw materials are thoroughly characterized and adequately controlled.
· Work with Pharmaceutical Development to identify key physicochemical properties and ensure they are controlled for optimized product development.
· Provide technical support and input to internal groups regarding processes and API quality requirements.
· Lead process chemistry on internal project teams to provide assessments, status, issues, and other relevant technical aspects of the corresponding program.
· Work closely with Legal for the execution of NDAs, Service and Supply Agreements and Intellectual Property strategies.
· Oversee the flow of the organization’s products from idea generation through production, including the planning of schedules, coordinating materials requirements, and formulating and recommending manufacturing policies and programs.
· Provides leadership and leads development efforts at CSPs through regular communications and project meetings.
· Review and approve master batch records(pre-execution) to ensure they are GMP compliant and addresses all aspects of a defined process. Review and approve batch records post-execution.
· Assist with writing of regulatory documents to support regulatory filings.
· Travels for kickoff meetings, audits, on-site meetings, and person in plant exercises.
Qualifications and Requirements:
· PhD in Chemistry or other related field with at least 10 years of industry experience.
· Demonstrated experience overseeing drug substance manufacturing activities.
· Experience overseeing drug substance 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 Supply Agreements
· Experience overseeing and coordinating CSPs with a focus on North America, Europe and Asia.
The above information on 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.