General Scope and Summary
SAGE is looking for a highly motivated individual to help advance our early development portfolio. The successful candidate will participate in the formulation and process development of difficult to solubilize drug molecules. The candidate will help develop and integrate formulation development strategies and plans in alignment with evolving cross-functional, project team and company goals and activities. The candidate will be responsible for delivering on critical program milestones using strong scientific judgement, thinking innovatively when needed, as well as driving operational activities in collaboration with SAGE’s external vendor partners.
Roles and Responsibilities
Helps develop strategy and formulation development plans for technically challenging, low solubility compounds in close collaboration with Pharmaceutical Development leadership, CMC Teams, Program Teams, and other related functions including: Discovery, Non-Clinical development, Clinical Operations, Process Development, Analytical Development, Quality and Regulatory
Actively participates as the Formulation Development lead on CMC teams and oversees formulation development and clinical manufacturing activities at external laboratories and manufacturing facilities
Authors formulation related sections for regulatory filings, development/technical reports and other development related documents
Actively communicates, collaborates with and contributes to other functional areas and drives to achieve the best development and business results for SAGE
Responsible for leading activities such as formulation development, delivery of clinical supplies, and developing scalable manufacturing processes in alignment with Company goals
Experience, Education and Specialized Knowledge and Skills
The successful candidate has a broad understanding of formulation development; a proven track record in developing and scaling-up formulations for oral administration for difficult to solubilize compounds; and implementing enabling technology platforms such as amorphous dispersions, lipids and nano particulates, for example, through human proof of concept. Experience with other non-oral routes of administration such as parenteral and depot formulations is a plus. Excellent scientific 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/outsourced model, utilizing external laboratories and manufacturing facilities, are a must.
Basic Qualifications
Advanced degree in Engineering, Materials Science, Pharmaceutics, Chemistry or related field
7+ years relevant small molecule formulation development experience in the pharmaceutical industry
Preferred Qualifications
Ph.D. degree preferred
Extensive experience with formulation technologies for low solubility molecules, such as amorphous dispersions, hot-melt extrusion, nanoparticles, lipids. Sterile, parenteral delivery systems, and other routes of administration such as topical and transdermal, a plus. A good understanding of phase-appropriate fit-for-purpose and innovative problem-solving strategies, based on program and company needs.
Experience reviewing of manufacturing batch records and other documentation
Experience and knowledge in scaling up solids and powder processing unit operations, and participating in tech transfer activities
Extensive knowledge about the interplay between bioavailability and PK/PD relationships, with respect to formulation modality is desired.
Experience with PBPK modeling and related software is a plus
Able to balance technical detail and problem-solving skills with strategic agility
Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies (up to 30% travel, if applicable)
Prior experience in authoring and reviewing drug product and Module 3/CMC sections of regulatory submissions a plus
Embraces SAGE’s core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
Excitement about the vision and mission of SAGE
Employment Type: Employee
Job ID: R000800 #Biotechnology #Careers #ThisIsSage
All 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.
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We 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.