miRagen Therapeutics is a publicly traded biopharmaceutical company headquartered in Boulder, Colorado. At miRagen, we are dedicated to improving patients’ lives through the discovery and development of innovative RNA-based therapeutics, with a specific focus on microRNAs. We are developing three clinical stage product candidates for the treatment of patients who suffer from a variety of diseases, including blood cancers, pathological fibrosis, and heart failure.
We currently seek a Formulations scientist who will thrive in a collaborative and fast-paced environment and be an integral part of Company’s CMC and drug development efforts. The position is responsible for developing robust formulations processes and identifying viable, cost-effective product formulations to advance miRagen’s clinical studies and drug candidate pipeline. Primary responsibilities include the following:
• Conducts experimental studies to develop formulation methods using standard and novel chemistries and analytical methods
• Designs pre-formulation screening and optimization studies to evaluate manufacturing feasibility and stability
• Prepares formulation development plans and formulation development reports.
• Manage the technology transfer to external contract organizations and collaborators
• Designs and performs stability studies of experimental and clinical batches
• Writes reports and/or provides documentation for regulatory submission
• Works collaboratively with cross-functional project teams
• Master’s degree in chemistry or related discipline and a minimum 4 years of work experience in biotech/pharmaceutical industry preferred. Consideration will be given to Bachelor’s level candidates with equivalent knowledge and experience.
• Demonstrated success developing formulations chemistries and drug delivery systems
• Demonstrated knowledge in chemical stability and characterization methods
• Proven ability to design, execute and analyze formulations studies with minimal supervision
• Experience developing scale-up protocols and methodologies
• Excellent time management skills and the ability to work with a sense of urgency
• Strong oral and written communication including the ability to present information clearly and logically
• Ability to prioritize and manage multiple projects to meet critical deadlines
• Strong attention to detail and problem-solving skills
• Works effectively in a team environment
• Requires periodic travel (10%-20%)