Associate Director, Process Development, Technical Operations

Company: SAGE Therapeutics
Location: Somerville
Posted on: May 3, 2021

Job Description:

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for chemical development and CMC-related aspects of chemical development involving clinical development programs in Phase 2, Phase 3 (including validation activities) and commercial programs. He/she/they will participate on the CMC project teams and collaborate closely with other functions including analytical and formulation development, non-clinical development, process development, quality, regulatory, and supply chain to support later stage development programs and support validation and commercialization activities.Roles andResponsibilities(Essential Functions)Oversees process development planning and execution for clinical phases including route development, process scale up, particle control, developing starting material and impurity control strategies, process validation and associated activities and manufacture of GMP drug substance.Actively contributes to IP / patent related activities.Partners closely with other functions including analytical and formulation development, non-clinical development, process development, quality, regulatory and supply chain.Participates on CMC teams and oversees execution of chemical development activities at external contract research organizations and manufacturing facilities.Authors and reviews drug substance related sections of regulatory filings.Drives to achieve the best development and business results for SAGE across all stages of development.Other tasks as assigned or as required for a given program.Experience, Education and Specialized Knowledge and SkillsThe successful candidate has a proven track record in chemical development for clinical stage programs using phase appropriate strategies. In addition, the candidate has a broad understanding of pharmaceutical development and CMC related activities, including process analytical development and formulation development. Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment as well as a proven ability to achieve results in a virtual setting with external contract research organizations and manufacturing facilities are a must.Other requirements are:Basic QualificationsAdvanced degree in Organic Chemistry, PhD preferred7+ years relevant small molecule chemical development, scale up and CMC experience in the pharmaceutical industryPreferred QualificationsDemonstrated ability to manage outsourced process development and manufacturing activities in a virtual environment both domestically and internationallyStrong problem-solving skills and ability to multitask and succeed in a fast moving and dynamic environment.Excellent verbal and written communication skills, ability to effectively work across levels, functions and companiesAbility to travel up to 30%Experience in writing regulatory documents and submissionsDirect experience in process validation and authoring CMC sections of NDAs is an advantage.Quality and project management experience is a plusEmbraces our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.Excitement about the vision and mission of SAGEAll qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.Employment Type:EmployeeNumber of Openings:1Job ID:R000606#Biotechnology #Careers #ThisIsSageAll qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.EEO is the LawEEO is the Law - Poster SupplementWe value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.JobSummaryJob number:R000606Date posted : 2021-02-25Profession: Research & DevelopmentEmployment type: Full timeSDL2017

Keywords: SAGE Therapeutics, Somerville , Associate Director, Process Development, Technical Operations, Other , Somerville, Massachusetts