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Director, Analytical Development

Employer
Sage Therapeutics
Location
Working from Home
Start date
Sep 25, 2022

View more

Discipline
Information Technology, Business/Data Analytics
Required Education
Doctorate/PHD/MD
Position Type
Full time

Job Details

General Scope and Summary

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

Roles and Responsibilities

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

  • Lead analytical activities conducted at CSPs, including method development and validations/transfers, stability studies, investigations, release testing of drug substance, drug product, and reference standards.

  • Manage quality control testing execution at multiple contract service providers (CSPs), ensuring contract sites deliver high quality analytical services for successful lot disposition and stability.

  • Actively communicate and collaborate with colleagues and third-party vendors to ensure optimal execution, data recording, and reporting of analytical activities that are performed according to agreed upon timelines in support of business objectives.

  • Provide Analytical and Quality Control representation during project team meetings; oversee quality control requirements for compliance with cGMP/CFR/ICH regulations and guidelines. 

  • Actively participate in the design of specifications in alignment with control strategies in a changing developmental environment for drug substances and drug products.

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

  • Author, review, and provide input for appropriate sections in regulatory filings including NDAs.

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

Experience, Education and Specialized Knowledge and Skills

The successful candidate has a broad understanding of analytical sciences and regulatory/GMP requirements, as well as a proven track record in analytical development for different clinical stage and commercial programs. Must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent communication and collaboration skills in a cross-functional 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.

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

  • Requires a strong background in Analytical Development, QC, and expertise in various separation and characterization techniques, as well as a thorough knowledge of cGMP, ICH, and relevant FDA guidelines.

  • Ability to travel up to 30% of time.

Preferred Qualifications

  • PhD in chemistry, chemical engineering, or related field preferred.

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

  • Demonstrated proficiency in hands-on analytical work with a broad range of analytical techniques; charged aerosol detection and mass spectrometry experience is a plus.

  • Proven track record in managing analytical and quality control aspects of development programs in advanced clinical stages.

  • Extensive experience in reviewing, organizing, and presenting analytical data.

  • Self-motived and results-driven individual to meet objectives and timelines while maintaining adherence to GMP compliance.

  • Detail oriented; hands-on problem-solving skills.

  • Excellent organizational and documentation skills.

  • Experience in managing people/group is a plus.

  • Excellent verbal and written communication skills; ability to drive decisions.

  • Thorough working knowledge of GMPs, ICH, and FDA guidelines.

  • Experience in authoring regulatory documents and submissions; direct experience in NDA and/or MAA writing is a plus.

  • Experience developing methods for analysis of APIs in complex lipid formulations is strongly desired.

  • Strong problem-solving skills and ability to solve complex analytical challenges at contract manufacturers.

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

  • 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.

Employment Type:Employee

Number of Openings:1

Job ID:R001304

#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.

EEO is the Law

EEO is the Law - Poster Supplement

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.

Company

Welcome To The Workplace With A Difference

Our vision is to fearlessly lead the way to create a world with better brain health – a vision we can only achieve with the help of our amazing team of highly knowledgeable, deeply passionate individuals.

At Sage, we believe that life is more than just a destination. We’re concerned with the journey, and we care deeply about everyone contributing to and benefiting from our own company journey. This means helping people discover the right path for them and carefully guiding colleagues along the way.

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Stock Symbol:

SAGE

Company info
Website
Phone
617-299-8380
Location
215 First Street
Cambridge
MA
02142
United States

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