Director of Manufacturing
miRagen Therapeutics, Inc. is a biopharmaceutical company founded to harness the power of microRNA (miRNA) biology. The company combines strong in-house expertise in microRNA biology and chemistry with external partnerships and academic collaborations that leverage best-in-class technologies. Together with its strategic partners, miRagen is focused on the discovery and development of innovative microRNA-based therapeutics in disease areas with high unmet medical need.
We currently seek a Director of Manufacturing to lead manufacturing efforts critical for the advancement of miRagen’s clinical drug candidates. The incumbent will contribute to the development of the CMC strategy for all manufacturing ranging from pre-clinical, PhI, PhII/III through commercial manufacturing Primary responsibilities include:
- Provide project leadership for API and drug product manufacturing and support formulation development, process development and transfer, for multiple product candidates.
- Manage clinical packaging for early phase programs.
- 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 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.
- Ensures timely delivery of quality drug product to support clinical and commercial development in alignment with corporate goals and objectives.
The position requires a minimum ten years of CMC development and manufacturing experience. Experience in oligonucleotide manufacturing is preferred but not requisite. The position also requires 5 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 parenteral 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.
- Strong background in parenteral drug manufacturing
- 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.