Scientist Genomic Medicine Bioanalytics QC
, Waltham, Massachusetts
Overview
From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.
Success Profile
Do you have what it takes for a successful career with Sanofi?
- Courageous
- Results-driven
- Proactive
- Problem-Solver
- Leadership
- Team player
Culture: Play to Win
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Growth
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Innovation
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Efficiency
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Collaboration
Benefits
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Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
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Financial
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
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Culture
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
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Work/Life Balance
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
Quote
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
Shannon Resetich
US Head Rare Diseases & Blood Disorders
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
Mouhamed Gueye
US Head Medical Rare Blood Disorders
Responsibilities
Position Overview/Department Description
This position resides within the Genomic Medicine Unit (GMU), a part of Sanofi’s CMC Development organization. The GMU Analytical Development group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of different cell therapy candidates. The group supports cGMP-compliant release and stability testing of clinical supplies at not only Sanofi manufacturing sites but also the Commercial Manufacturing Organizations (CMO).
The selected candidate will oversee CMO QC activities by reviewing data coming out of the labs and driving timely closure of the CMO’s and internal Quality management Systems (QMS). A strong candidate will have experience with GMP principles and know how to critically review and evaluate quality-controlled records and data. The candidate will also need to help the CMO troubleshoot and investigate invalids and Out of Specifications/Trend (OOS/T) in addition to reviewing SOPs and Technical Study protocols and reports.
Responsibilities
- Support in-process and release testing of cellular therapies out of our CMO facilities by managing testing and review workflows.
- Plan, prioritize and execute simple and complex tasks and logistics in order to expedite final drug product disposition with a high-Quality standard.
- Perform thorough quality control technical review of executed quality records associated with analytical testing and deliver on time.
- Review, analyze, trend, and interpret analytical data for in-process, final drug product, stability, and comparability testing with minimal supervision.
- Write technical reports & SOPs, including clear and concise technical presentations and discussions.
- Support and facilitate Technology Transfers into new CMOs.
- Manage and work through CMO-owned analytical testing laboratory investigations and assist with trouble shooting analytical methods, deviations, OOS/OOT investigations, and change controls and deliver these on-time.
- Ensure timely completion and delivery of the CoA’s from the CMO site.
- This is a remote role and may require up to 15% travel
Basic Qualifications
- Ph.D. in Molecular Biology/Biochemistry/Biology or related discipline or Master’s degree with a minimum of four years of relevant industry experience, or a Bachelor’s Degree with a minimum of six years of relevant industry experience
- GMP experience either in QC or as an auditor in QA.
- Experience with molecular biology techniques, immunoassays, cell culture and cellular based assay development, especially including Flow Cytometry.
- Candidate must have an active passport.
Preferred Qualifications
- Experience in qualification/validation and transfer of analytical methods.
- Experience using Quality by Design (QbD) principles and have used Design of Experiment (DOE) approaches for method development/optimization.
Experience utilizing various forms of statistical analysis for data analysis.
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.
