Associate Director/Principal Scientist, Formulation Development

General Scope and Summary

The successful candidate will participate in the formulation and process development of low solubility 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, as well as driving operational activities in collaboration with SAGE’s external partners.

Roles and Responsibilities

• Help 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 Pre-Formulation, Discovery, Non-Clinical development, Clinical Pharmacology, Clinical Operations, Process Development, Analytical Development, Quality, and Regulatory.

• Actively participate as the Formulation Development lead on CMC teams and oversee formulation development and clinical manufacturing activities at external laboratories and manufacturing facilities.

• Author formulation-related sections for regulatory filings, development/technical reports, and other development-related documents.

• Actively communicate, collaborate with, and contribute to other functional areas and drive to achieve the best development and business results for SAGE.

Experience, Education and Specialized Knowledge and Skills

The successful candidate has a broad understanding of formulation development and a proven track record in developing and scaling-up formulations for oral administration for low solubility compounds using enabling technology platforms such as amorphous dispersions, lipids, and nanoparticles (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, 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; PhD preferred.

• 8+ years of relevant small molecule formulation development experience in the pharmaceutical industry.

Preferred Qualifications

• Extensive experience with formulation technologies for low solubility molecules, such as amorphous dispersions, hot-melt extrusion, nanoparticles, and lipids. A good understanding of phase-appropriate fit-for-purpose and innovative problem-solving strategies, based on program and company needs.

• Working knowledge of early phase appropriate formulation approaches such as API in capsule, solutions, and suspensions.

• Responsible for leading activities such as formulation development, delivery of clinical supplies, and developing scalable manufacturing processes in alignment with Company goals.

• Review of manufacturing batch records and other documentation.

• Experience and knowledge in scaling-up liquids, solids, and powder processing unit operations and participating in technical transfer activities.

• Extensive knowledge about the interplay between bioavailability and PK/PD relationships with respect to formulation modality is desired.

• 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 is a plus.

• Embraces SAGE’s Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the science, vision, and mission of SAGE.

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

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.

EEO is the Law

EEO is the Law - Poster Supplement

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.