General Scope and Summary

　　SAGE Therapeutics is searching for a quality-oriented and resourceful Senior Manager, Quality Control for an integrated role that will contribute to the CMC aspects, supporting commercial manufacturing of novel CNS medications. As a key member of the Quality Control team, the successful candidate will work closely with other functions including Quality Operations, Process Development, and Regulatory Affairs to support commercial programs. The candidate will serve as the Product Lead for all aspects of the analytical activities.

　　Roles and Responsibilities

　　Lead the product lifecycle management of commercial programs to assure GMP compliance and regulatory expectations.

　　Manage analytical/QC data generated at third party labs for a late phase and commercial programs in order to advance Sage’s fast growing portfolio of products.

　　Provide Quality oversight of GMP QC activities at Contract Service Providers, including Quality review of analytical data for completeness, ensuring accuracy and compliance.

　　Demonstrate an in-depth understanding of reviewing analytical data associated with analytical procedures, compendial procedures, release testing, and stability studies for drug substance and drug product.

　　Manage late phase reference materials activities conducted at third party labs, including organization of analytical data, shipping coordination, and timely provision of COAs associated with reference materials qualification.

　　Monitor and communicate metrics on quality control activities for a given program.

　　Manage stability studies for drug substance and drug product, including sample pull schedules, review protocol, reporting, and raw data and statistical trending of the data set from the studies conducted.

　　Communicate to stakeholders in a timely manner.

　　Partner closely with other functions, including Quality Assurance, Process Development, and Regulatory Affairs to ensure programs are effectively supported and high-quality standards are maintained.

　　Manage analytical activities conducted at third party labs, including method validations, method transfers, and analytical investigations of drug substance and drug product.

　　Author, review, and provide data for appropriate sections in regulatory filings such as INDs/IMPDs/NDAs.

　　Perform other duties as assigned by manager.

　　Experience, Education and Specialized Knowledge and Skills

　　The successful candidate has a good understanding of the Quality Control function, analytical sciences, and GMP requirements. Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent 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

　　Bachelor’s degree in analytical chemistry, chemistry, or related field.

　　5+ years of relevant QC/analytical experience in the pharmaceutical industry.

　　Preferred Qualifications

　　Background in quality control and/or analytical and an understanding of analytical techniques such as HPLC, GC, UV-Vis, CAD, KF, FTIR and wet chemical methods are required.

　　7+ years of relevant QC/analytical experience in the pharmaceutical industry.

　　Proven track record in reviewing and organizing analytical documentation.

　　Demonstrated proficiency in data analysis, data entry, and trending.

　　Demonstrated proficiency in hands-on analytical/QC work and willingness to learn how to solve more complex analytical challenges.

　　Experience in CAD detection is a plus.

　　Detail-oriented and ability to make keen observations.

　　Good working knowledge of GMPs, ICH, and relevant FDA guidelines.

　　Experience in writing regulatory documents and submissions is a plus.

　　Ability to travel up to 10% of time.

　　Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.

　　Strong team player that has a customer service approach and is solution-oriented.

　　Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

　　Possesses strong written and verbal communication skills.

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

　　Excitement about the vision and mission of Sage.

　　Benefits and Compensation

　　The base salary hiring range for this position is $129,059 - $177,456.*

　　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 (https://careers.sagerx.com/media/ngth5cdv/sage-us-benefits-guide.pdf) .

　　*Base salary ranges are periodically reviewed and subject to change.

　　#LI-Remote

　　Protected personal characteristics include: age, race, ancestry, color, sex, national origin, sexual orientation, gender identity or expression, religious creed, mental or physical disability, pregnancy, genetic information, marital or civil union status, participation in the uniformed services of the United States, or any other characteristic protected under applicable federal, state or local law. To learn more, see Sage's Anti-Harassment and Equal Opportunity Policy