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Stability Lead-Waltham, MA

Waltham, Massachusetts

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.

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  • HEALTH AND WELLNESS PROGRAMS

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    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

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Responsibilities

JOB DESCRIPTION:

We are seeking a highly-motivated Stability Lead to join a dynamic Quality and Regulatory team.   

The Stability Lead will support operational and technical aspects of clinical/commercial drug substance, drug product, reference standard, and placebo GMP stability programs.

The successful candidate will have responsibilities is to ensure compliance and support of company Standards, Practices, and SOPs as well as ICH and global regulatory guidelines. This includes design of stability protocols, retest/expiry dating for clinical and commercial products, providing stability sections for regulatory submissions, technical assessment of stability data, specification changes and investigations.  The Stability Lead routinely works with CMO/CLOs to ensure timelines are met for release and stability testing of product.

RESPONSIBILITIES:

  • Ensures statistical methods comply with regulations, guidances and standards published by ICH, FDA, EMA and other regulatory authorities
  • Designs and manages studies. Collaborates with CLOs to ensure proper testing and reporting of stability samples
  • Assigns retest date/expiry to drug substance, drug product, and reference standard based on analyses of existing data set
  • Proactively trends and evaluates stability data
  • Authors stability reports for regulatory submissions
  • Authors stability assessments for Anomalous Results (ARs) and Out of Trend (OOT) testing results
  • Participates in meetings and contributes toward the goals of the CMC team. Contributes to major/critical manufacturing investigations with potential product impact, and leads stability investigations (deviations, OOS, cross-site and cross-functional).

BASIC QUALIFICATIONS:

  • A BS or MS degree in science (i.e. Analytical Chemistry, Biochemistry, Biology, Chemistry, Organic Chemistry, Pharmaceutical Chemistry, Protein Chemistry) or a similar technical field of study.
  • A minimum of 6 years of relevant industry experience, with at least a minimum 3 years of direct experience in stability / formulation of biological and/or small molecule products in the Pharmaceutical industry; 8 years industry experience preferred 
  • Knowledge of analytical methods, ICH Guidelines, and strong ability to analyze data.
  • Expertise on analytical method transfer especially on biochemical and biophysical method to CLO
  • Experience on handling, management of qualified materials and reagents required in biological assays and biochemical assay 
  • Experience on  sample management with CLOs and analytical method validation
  • Good understanding of statistical analysis and interpretation of data. Proficiency with cGMPs and experience with Microsoft Office (Word, Excel, PowerPoint) and SAS JMP are required.
  • Strong technical writing skills and communication skills are essential  

ABOUT BIOVERATIV:

Bioverativ is a global biotechnology company dedicated to transforming the lives of people with hemophilia and other rare blood disorders through world-class research, development and commercialization of innovative therapies. Launched in 2017 as an independent company spun out of Biogen’s hemophilia business, we build upon a strong heritage of scientific innovation and are committed to actively working with the rare blood disorders community. The company’s mission is to create progress for patients where they need it most and its hemophilia therapies when launched represented the first major advancements in hemophilia treatment in more than two decades. For more information, visit www.bioverativ.com or follow @bioverativ on Twitter.

We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.  

VEVRAA Federal Contractor

We Request Priority Protected Veteran and Disabled Referrals for all our locations.

Bioverativ is an E-Verify Employer in the United States

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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