Director, Analytical Development

General Scope and Summary

SAGE Therapeutics is searching for a technical leader for a highly visible role as Director, Analytical Development. The successful candidate will be responsible for analytical method development and related activities at third party laboratories for early phase development programs (IND-enabling through Phase 2), and will collaborate closely with other CMC related functions including process research, formulation development, non-clinical development, technical operations, quality and regulatory in order to advance Sage’s fast growing portfolio of products.

Roles and Responsibilities

• Oversee analytical strategy, planning and execution for Sage’s early phase portfolio of products and work closely with other CMC related functions.

• Oversee all analytical activities conducted at third party labs including structure elucidation, method development and validation, stability studies, method transfer, testing of clinical materials and qualification and maintenance of reference standards.

• Support GMP, GLP and GCP activities, including investigations.

• Authors, reviews, and provides phase appropriate input for relevant sections of INDs. NDAs and other regulatory filings.

• Responsible for authoring/reviewing/approving deviations, investigations, OOS/OOT, CAPAs, data interpretation, data presentation, statistical analysis, and trending.

• Provide leadership in the design of phase appropriate specifications in alignment with control strategies in a changing developmental environment for drug substances and drug products.

• Actively contribute to program teams and ensure alignment of analytical activities with the program development plans.

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

• Leads and manages the Analytical Development team, providing guidance and support, coaching the team to grow and develop in line with Sage’s culture and core values

Experience, Education and Specialized Knowledge and Skills

The successful candidate has a broad understanding of analytical sciences and regulatory/GMP requirements, and a proven track record in analytical method development for early clinical stage programs. QC experience is preferred. 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 laboratories and manufacturing facilities are a must.

Basic Qualifications

• Advanced degree in Chemistry, Chemical Engineering or related field, PhD preferred

• 10+ years of relevant small molecule analytical experience in the pharmaceutical industry

• Strong background in Analytical techniques and expertise in various separation and characterization techniques; thorough knowledge of cGMP, ICH, and relevant FDA guidelines

• Experience leading and managing technical teams

Preferred Qualifications

• Practical experience with a broad range of analytical techniques, charged aerosol detection and/or, mass spectroscopy detection is a plus

• Proven track record in managing analytical aspects of development programs in the clinical stage,

• Strategic and leadership abilities as well as hands on problem solving skills. Ability to solve complex analytical challenges at contract manufacturers.

• Excellent verbal and written communication skills, ability to effectively work across levels, functions, and companies

• Ability to multitask and succeed in a fast-moving and dynamic environment

• Experience in writing regulatory documents and submissions

• Embraces our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways

• Excitement about the vision and mission of Sage

• CMC project management skills a plus

• Ability to travel up to 10% of time

Benefits and Compensation

The base salary hiring range for this position is $193,182 - $265,626.*

• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
• This position is eligible to participate in the Company’s annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
• To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.

• Base salary ranges are periodically reviewed and subject to change. #LI-Remote