We currently seek a Director, Analytical Chemistry to lead efforts critical for the advancement of miRagen’s clinical drug candidates. The incumbent will contribute to the development of the CMC strategy from early clinical through commercial. Primary responsibilities include:
• Provide project leadership for analytical development in support of API and drug product manufacturing, stability, formulation development, process development and method transfers, for multiple product candidates.
• Work with cross-functional program teams providing budgets, updates, and project management support required to achieve pre-clinical and clinical development goals and timelines.
• Support the CMO/contractor selection process with CMO’s, suppliers, and internal stakeholders to ensure timely release of drug product required for all clinical studies.
• Prepare CMC documents/sections for product submissions including IND, NDA, NDS, etc., for both US and Ex US regulatory authorities.
• Support Quality audits of CMOs.
• Coordinates testing to support clinical and commercial development in alignment with corporate goals and objectives.
• Review, investigate, trend, analytical release and stability testing data.
• Establishes and maintains specifications and writes/reviews protocols.
The position requires a minimum ten years analytical and extensive QC experience. Experience in the analysis and characterization of oligonucleotides is preferred but not requisite. Strong background and support for implementation of USP, EP and compendia methods. Position also requires 5 five years of management/supervisory experience, and proven ability to work collaboratively and effectively on a multi-disciplinary team.
• Solid understanding of all facets and phases of CMC drug development.
• Expertise in the implementation and qualification/ validation of analytical methods.
• Thorough knowledge of GMP regulations required for testing of finished product for human clinical studies.
• Knowledge of CMC requirements for regulatory filings covering all phases of pre-clinical and clinical development in both the US and ex-US markets.
• Demonstrated ability to manage CRO and CMO contracts and activities.
• Proven track record of moving compounds from pre-clinical toxicology studies through IND filing and human clinical studies.
• Demonstrated technical and project management capabilities.
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
• Demonstrated success managing multiple assignments with timely and accurate output.