Director, Analytical Chemistry

Company: Edgewise Therapeutics
Location: Boulder
Posted on: November 22, 2022

Job Description:

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.
About the PositionEdgewise Therapeutics is dedicated to advancing small molecule drug development programs focused in rare muscle disorders. This position is responsible for providing oversight for all the analytical development activities associated with drug substance and drug product to support preclinical studies, clinical development, and registration. The incumbent will be responsible for ensuring oversight of all the development activities and testing performed by contract laboratories, including starting materials, in-process, release, and stability testing for clinical development and pre-commercial.
Primary Responsibilities

• Responsible for the development, validation, and transfers of all analytical methods from pre-clinical through clinical development.
• Participate in selection of contract manufacturing organizations and contract laboratories and oversee development and validation of methods for reference standards, starting materials, intermediates, release, and stability testing of both drug substance and drug product.
• Author and provide technical review of relevant Chemistry, Manufacturing and Controls (CMC) sections in regulatory dossiers.
• 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.
• 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.
  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.
  • Experience managing analytical CMC development of drug substance and drug products from pre-clinical through registration and approval.
  • Expert level knowledge of analytical method development and method qualification/validation
  • Experience interpreting ICH and FDA guidance for analytical method qualification/validation, stability testing.
  • Extensive knowledge of GLP and cGMP requirements, appropriate regulatory guidance and current industry practices for analytical development.
  • Experience authoring analytical modules for regulatory submissions in all phases of development.
  • Experience with identification and qualification of impurities and degradation products.
  • Experience with setting specifications for drug substance and drug product and qualifying reference standards.
  • 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.
  • 
    Salary range: $155,000 - $225,000, title and salary commensurate with experience
    Send resume and cover letter to recruiting@edgewisetx.com

Keywords: Edgewise Therapeutics, Boulder , Director, Analytical Chemistry, Executive , Boulder, Colorado