Director/Senior Director, Formulation Dicerna Pharmaceuticals
Experienced formulator and leader with knowledge of the development of pharmaceutical delivery systems for biologicals, ideally lipid-based delivery systems. Must have a proven ability to bring creativity and new approaches to solving research and development challenges. The ideal candidate will have experience in the development of formulations and systems for oligonucleotide therapeutics. Candidate should have experience in the in vitro and in vivo drug delivery development settings.
Design and direct all aspects of formulation, specifically evaluation, development, scale-up, and manufacture of formulations for early and late stage clinical studies through validation batches to commercial manufacturing of drug products;
Develop new formulations for oligonucleotide therapeutics, lead internal development of new formulation technologies;
Ensure compliance with applicable guidelines, i.e. FDA, GMP, ICH
Experience working closely with Chemistry, Toxicology, DMPK, and Clinical functions;
Experience with CMC and cGMP regulatory interactions, documentation and submissions;
Direct CRO?s, external partnerships and collaborations and insure that performance goals and milestones are met;
Represent the company and conduct presentations at both internal and external meetings:
Strong leadership experience with PhD scientists and associates to mentor, motivate and develop a high performing team.
Ph.D. or PharmD and a minimum 8 -10 years post-graduate experience with demonstrated record of moving drugs from research to development and a thorough understanding of translational aspects of drug development.
Proven ability to lead development teams in the pharmaceutical/biotech environment and obtain meaningful results;
Ability to define and communicate development goals that characterize the therapeutic potential of RNAi directed target gene regulation;
Solid technical ability and hands-on experience
Excellent project management skills, a strategic and results-oriented approach to operational excellence, proven ability to develop productive professional relationships, sound operational judgment;
Experience in managing CRO?s and CMO?s as well as multidisciplinary collaborations with industry and academic investigators;
Demonstrated ability to work effectively in a team environment, manage multiple priorities, exercise sound judgment, be well organized, take initiative, be flexible, work well under pressure and produce accurate and timely work.
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