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Associate Director/Director, Process Development and Manufacturing

Company: Morphic Therapeutic
Location: Cambridge
Posted on: November 17, 2018

Job Description:

About Morphic Therapeutic Morphic Therapeutic Inc. is a biotechnology company developing a new generation of oral integrin therapies. Drawing on integrin biology breakthroughs from the lab of noted entrepreneur and scientific founder Tim Springer, Morphic has built a robust pipeline of integrin inhibitors for the treatment of fibrosis, autoimmune disease and cancer. Morphic was created in 2015, raised $51.5M Series A in 2016 and $80M Series B in 2018 to bring multiple programs into the clinic. We recently announced a collaboration with AbbVie on a subset of our fibrosis programs. Under the terms of the agreement, AbbVie paid Morphic an upfront payment of $100 million for exclusive license options on product candidates directed at multiple targets. Moprhic retains co-development rights in liver indications. Morphic is located in the AstraZeneca BioHub in Waltham, MA. We seek a highly talented and motivated scientist to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity. Job description Morphic is searching for a creative, resourceful and dynamic individual to join our growing company to lead the process chemistry function within CMC team. The successful candidate needs to demonstrate a proven track record of developing and manufacturing API for clinical development from early stage up to commercialization. This candidate should also have direct experience working with CROs/CDMOs and authoring drug substance sections for regulatory filings. The Associate Director/Director will represent process chemistry on cross-functional teams and/or lead cross-functional teams, both within Morphic and with alliance or CDMO partners. Responsibilities Serve as the drug substance process technical lead Responsible for drug substance process design, optimization, scale-up, technology transfer and validation with a focus on clinical manufacturing to meet regulatory and quality expectations while integrating quality risk management principles Work with project teams to identify drug substance requirements Manage and optimize aggressive project timelines Oversee the development of technical solutions to insure drug substance processes can be successfully demonstrated and delivered Ensure relevant data is captured in reports provided by external CROs/CDMOs Responsible for writing, reviewing scientific reports and drug substance sections in regulatory filings Contribute to IP/patent related activities for process chemistry Build collaborative and long-term relationships with CDMO partners Assist in the development and communication of department goals and strategy YourMembership. Keywords: Manufacturing Director, Location: Cambridge, MA - 02142

Keywords: Morphic Therapeutic, Boston , Associate Director/Director, Process Development and Manufacturing, Executive , Cambridge, Massachusetts

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