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. 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 the Head of Pharmaceutical Development, program and CMC teams, and 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 with, 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 will have a broad understanding of drug product formulation and CMC development, as well as 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 through human proof of concept. Experience with other non-oral routes of administration, such as parenteral and depot formulations, is a plus. Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans and recommendations are key. 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 Pharmaceutics, Chemistry, Engineering or related field; Ph.D. preferred.

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

• 5+ years of extensive experience with solid oral drug product formulation technologies for low solubility molecules, such as spray dried dispersions, hot-melt extrusion, nanoparticles, lipids, tablets, and capsules.

Preferred Qualifications:

• Experience working in an outsourced model utilizing external laboratories and manufacturing facilities.

• 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.

• Experience in the development, review, and approval of manufacturing batch records and other relevant documentation.

• Experience and knowledge in scaling up liquids, solids, and powder processing unit operations as well as participation in technical transfer activities.

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

• Ability 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).

• Prior experience in authoring and reviewing drug product and Module 3/CMC sections of regulatory submissions is a plus.

• CMC project leadership experience is a plus.

• Excitement about the vision and mission of Sage.

Employment Type:

Employee

Job ID:

R0