Manager, Quality Control - Analytical Development

Sage Therapeutics

Cambridge, MA 02238

Posted 1 month ago

Job Description

**General Scope and Summary**


Sage Therapeutics is searching for a resourceful, integrative analytical thinker for a role that will contribute to the Analytical/Quality Control (QC) function, supporting successful scale-up and manufacturing of novel CNS medications. As a key member of the Analytical Development and Quality Control team, the successful candidate will work closely with other functions, including Quality Operations, Formulation Development, Process Development, and Regulatory Affairs to support late-stage development and commercial programs.


**Roles and Responsibilities**


+ Responsible for managing quality control and related activities for late phase programs in order to advance Sage’s fast-growing portfolio of products.


+ Oversee GMP QC activities at Contract Service Providers (CSPs), including quality review of analytical data for completeness, ensuring accuracy and compliance.


+ Manage analytical activities conducted at CSPs, including method validations/transfers, stability studies, investigations, release testing of drug products, drug substances, intermediates, starting materials, and reference standards.


+ Responsible for deviations, investigations, and OOS/OOT reports, as well as initiation and execution of change controls and material specifications.


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


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


+ Communicate to stakeholders in a timely manner.


+ Perform other tasks as assigned or as required for a given program.


**Experience, Education and Specialized Knowledge and Skills**


The successful candidate has a good understanding of small molecule analytical sciences, quality control and regulatory/GMP requirements, and a proven track record in analytical development/quality control for late-stage and commercial programs. 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 scientific field.


+ 4+ years of relevant QC/analytical experience in the pharmaceutical industry.


+ Requires a background in quality control or analytical development, expertise in analytical techniques, and a thorough knowledge of cGMP, ICH, and relevant FDA guidelines.


**Preferred Qualifications**


+ Master’s degree in analytical chemistry, chemistry, or related scientific field.


+ 6+ years of a proven track record in managing quality control aspects of programs in advanced clinical and/or commercial stage.


+ Experience with chromatographic techniques and analytical data review.


+ Knowledge of GMP, ICH, and relevant FDA guidelines.


+ Experience in writing regulatory documents and submissions is a plus.


+ Demonstrated proficiency in hands-on analytical techniques and a willingness to learn how to solve complex analytical challenges at CSPs.


+ Detail oriented and ability to make keen observations.


+ Excellent organizational and documentation skills.


+ Excellent verbal and written communication skills.


+ Strong problem-solving skills and ability to multitask and succeed in a fast moving and dynamic environment.


+ Ability to travel up to 20% of time.


+ 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.


**Employment Type:**


Employee


**Number of Openings:**


1


**Job ID:**


R001299


**\#Biotechnology #Careers #ThisIsSage**


All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.


All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.


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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.

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



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