We currently seek a Vice President, CMC to lead all process development and manufacturing efforts critical for the advancement of miRagen’s clinical drug candidates. The incumbent will be a member of the senior leadership team and contribute to the development of the CMC strategy for all manufacturing ranging from pre-clinical, Phase I, Phase II/ Phase III through commercial manufacturing. Primary responsibilities include:
• Provide technical oversight and project leadership on all Supply Chain and CMC development activities including formulation development, process development and transfer, Quality by Design (QbD) manufacturing, validation, stability, and data review.
• Work with cross-functional program teams providing budgets, updates, and project management support required to achieve pre-clinical and clinical development goals and timelines.
• Drive the CMO/contractor selection process and manage the supply chain operations 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.
• Facilitate the preparation process for internal and external audits.
• Direct all aspects of clinical trials material for phase 1-3 studies
• Establish and oversee process development strategy and translate into deliverable and milestones to ensure phase-appropriate manufacturing processes; provide informal and formal updates to senior/executive leadership.
• Manage, coach, and develop direct reports and be an active participant in the interview and selection process for future hires.
• Ensures timely delivery of quality drug product to support clinical and commercial development in alignment with corporate goals and objectives.
The position requires a Ph.D. in Chemistry, Chemical Engineering or related field and a minimum ten years of supply chain management and CMC development experience. Experience in oligonucleotide manufacturing is preferred but not requisite. Also requires a minimum five years of management/supervisory experience, and proven ability to work collaboratively and effectively on a multi-disciplinary team.
Other Required Knowledge and Skills:
• Solid understanding of all facets and phases of CMC drug development.
• Strong expertise in API development and GMP regulations required for the manufacturing 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 negotiate and manage CRO and CMO contracts and activities.
• Knowledge of non-oral formulation development and non-oral delivery systems.
• Proven track record of moving compounds from pre-clinical toxicology studies through IND filing and human clinical studies.
• Demonstrated technical and project management capabilities.
• Adept at creating and communicating a clear vision among direct reports, effectively aligning resources and motivating teams to achieve goals.
• 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.