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, Analytical Development will lead DiCE’s preclinical to clinical analytical development activities and oversee the testing and release of drug substance and drug product for DICE’s small molecule programs at contract service providers (CSPs).
· Design and execute phase-appropriate analytical strategies at CSPs including analytical method development, qualification and validation for drug substance and drug product.
· Develop and set specifications for raw materials, intermediates, drug substance, excipients and drug product.
· Design and manage stability programs for non-GMP and cGMP drug substance and drug product batches and provide guidance for shelf-life and expiry dating.
· Establish workflows and procedures for analytical and quality control activities at DiCE.
· Develop strategies for reference standards program, coordinate sourcing, ensure inventory, plan and execute testing and retesting activities, and manage shipments of reference standards across CSP network.
· Manage and review deviation events and OOS/OOT investigations at CSPs in coordination with CMC counterparts, QA and regulatory team members, as appropriate.
· Author, review and approve various analytical reports in a timely manner to support drug substance and drug product development and manufacture, and regulatory filings.
· Support regulatory submissions by drafting and reviewing analytical sections of INDs, IMPDs, and NDAs, and ensure compliance with current regulatory requirements.
· Represent analytical function in CMC teams and project meetings, and work closely with cross-functional teams to meet project timelines and goals.
· Keep abreast of latest progress in analytical development, cGMP requirements, and regulatory guidances.
Qualifications and Requirements:
· PhD in analytical chemistry or related discipline with more than 10 years of industry experience or BS/MS degree with more than 15 years industry experience.
· Experience with analytical development of small molecules and solid oral dosage forms from preclinical to late-stage clinical development.
· Extensive experience working with drug substance and drug product CSPs and subject-specific CSPs on analytical projects.
· Experience with identification and qualification of impurities and degradation products.
· Experience with setting specifications for drug substance and drug product and qualifying reference standards.
· Extensive knowledge of GLP and cGMP requirements, appropriate regulatory guidances and current industry practices for analytical development.
· Demonstrated scientific excellence, technical leadership, and creativity.
· Proven project management skills and productive collaboration with cross-functional teams.
· Ability to deliver under tight timelines and adapt to changing project needs.
· Ability to work on multiple projects at the same time.
· Ability to communicate, organize, and write well.
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.