Werewolf Therapeutics: CMC outsourcing managerCompany Background:Cancer immunotherapy targeting immune checkpoints is demonstrating transformative anti-tumor activity in clinical use, and additional immune regulatory pathways are emerging with the expectation that therapeutics targeting these pathways will rapidly enter clinical development.Werewolf Therapeutics Inc. is an exciting start-up biotech, located in the heart of Cambridge MA, focusing on the development of novel biologic agents for the treatment of cancer.We are currently seeking experienced scientists to join our rapidly growing team. Description of Role & Requirement:The successful candidate will be a driven scientist, with strong problem-solving skills and demonstrated expertise in biologics manufacturing.H/she will be responsible for managing outsourced manufacturing programs and maintaining highly productive relationships with CMOs.H/she will be required to develop manufacturing program strategies, maintain timelines, strive for high quality product, and provide updates to senior management.This will include proposing/reviewing scopes of work, data analysis, facilitating team meetings, protocol/batch record review, budgeting, and coordination with internal development team members H/she will be expected to thrive in a dynamic start-up environment. Requirements: A MS or Ph.D in Biology, Biochemistry or related field, as well as 5+ years of relevant experience is required.Experience in biologics development (drug substance and drug product manufacturing)In depth knowledge of cell line construction, upstream/downstream process development, and analytical method developmentExperience managing relationships with biologics CMOsProven track record with managing multiple projectsFamiliarity with CMC/Quality and cGMP guidance documentsDirect experience at a CMO is a plusStrong written and oral communication skills are a must.Strong organizational skills.Demonstrated ability to work as part of a team to execute plans and deliver results is also necessary.
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