General Scope and Summary
SAGE Therapeutics is searching for a highly motivated analytical chemist to join our Pharmaceutical Development analytical team. This person will play an important role in the discovery and development of SAGE’s novel and emerging development and commercial CNS pipeline.
The successful candidate will be part of a team responsible for planning and executing all analytical method development and characterization activities for drug substances and drug products for early clinical development of new and existing chemical entities in all phases of development, and life cycle development opportunities. In addition, the candidate will support CMC activities to enable drug substance and drug product development, helping the company evaluate platforms for various routes of administration and bioavailability enhancing technologies for SAGE’s compound portfolio.
SAGE Therapeutics is a virtual pharmaceutical company. In addition to collaborating with a talented internal team of scientists in Nonclinical Research, Pharmaceutical Development, Quality, and Regulatory, the candidate will work closely with external contract research organizations (CROs) to advance SAGE’s rapidly growing pipeline.
SAGE Therapeutics' Pharmaceutical Development group is part of a highly integrated team including Nonclinical Development, Quality Assurance and Operations, CMC Regulatory, and Supply Chain. The successful candidate will be a strong, collaborative contributor to this broader team.
Roles and Responsibilities
- Responsible for executing all analytical method development and characterization for drug substances and drug products for early clinical development, including, but not limited to: in-process control/analysis of drug substance route development, impurity isolation and characterization, finished drug substance analysis, pre-formulation, characterization of drug product formulations, and development of discriminating tests for drug product performance.
- Responsible for overseeing the qualification of test methods for cGMP drug substance and drug product manufacturing at external contract research organizations and manufacturing partners.
- Authoring/developing method qualification protocols.
- Assisting in the design and development of phase-appropriate quality control strategies, specifications, and stability studies for drug substance and drug product.
- Partnering closely with other functions, including: Chemical Development, Formulation Development, Late-Stage Process Development, Quality Assurance, CMC Regulatory, and Clinical Supply Chain.
- Representing Analytical Development on SAGE Therapeutics CMC teams.
- Authoring Analytical Development sections and contributing to drug substance and drug product-related sections of regulatory filings.
Experience, Education and Specialized Knowledge and Skills
The candidate has a basic understanding of Pharmaceutical Development and CMC-related activities, including process analytical development, with an ability oversee and execute the qualify test methods to advance clinical material. 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:
- Advanced degree in Physical or Analytical Chemistry required.
- 7+ years' relevant small molecule analytical development and CMC experience in the pharmaceutical industry.
- PhD degree preferred.
- A mechanistic understanding of pharmaceutical instrumental analysis, including liquid and gas chromatography with UV, charged aerosol, and FID detection.
- Thermal analysis experience, including differential or isothermal calorimetry thermogravimetric analysis.
- Sample preparation experience including derivatization or liquid/solid phase extraction.
- A strong understanding of thermodynamic properties and mass transfer behavior, including polymorph thermodynamics, mass transfer behavior of enabling formulations such as stabilized amorphous states, nano-formulations, or soft gel lipids.
- A working understanding of spectroscopic characterization to solve problems.
- A demonstrated ability to manage outsourced analytical development activities in a virtual environment.
- Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and companies.
- Experience in writing regulatory documents and submissions preferred.
- Embraces Sage’s Core Values: Put People First, Do Big, Be Accountable, Grow through Learning & Change, and Work Fun.
- Excitement about the vision and mission of Sage.
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