Associate Director, Formulation Development

Location
Cambridge, Massachusetts
Salary
Competitive salary for the Boston market +Benefits
Posted
Oct 07, 2020
Closes
Nov 06, 2020
Ref
R000475
Field of specialization
Biotechnical
Work Function
Development-Product
Job Type
Full time

General Scope and Summary

 

 

The successful candidate will participate in the formulation and process development of difficult to solubilize drug molecules. He/She will help develop and integrate innovative formulation development strategies and plans, in alignment with evolving cross-functional and project team goals and activities. The candidate will also oversee strategic vendor partner selection and drive technical and operational activities in collaboration with SAGE’s external partners.

 

 

Roles and Responsibilities

  • Helps develop strategy and formulation development plans for technically challenging, low solubility compounds in close collaboration with Tech Ops/Pharmaceutical Development leadership, CMC Teams, Program Teams, and 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 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

 

 

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 difficult to solubilize compounds using enabling technology platforms such as amorphous dispersions and nanoparticulates, for example, through proof of concept. Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment, as well as 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, Ph.D. preferred
  • 8+ years relevant small molecule formulation development experience in the pharmaceutical industry

 

 

Preferred Qualifications

  • Extensive experience with formulation technologies for low solubility molecules, specifically the development and scale-up of spray dried amorphous dispersions.  Experience with other enabling technologies such as hot-melt extrusion, nanoparticles, lipids, etc. a plus.  Savviness for balancing between implementing both fit-for-purpose and innovative approaches to problem solving, based on program requirements.
  • Responsible for managing pre-formulation, formulation development, delivery of clinical supplies, development of efficient and scalable manufacturing processes in alignment with Company goals
  • Review 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
  • Strategic view as well as hands-on problem-solving skills
  • 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