Job title:Principal Investigator, Pear River, NY
Location: Pear River, NY
About the Job
This position is within the Protein Sciences Manufacturing group and will support Manufacturing Operations by completing deviation investigations. The candidate will work cross-functionally with various support groups to implement effective and preventative actions as well as perform a thorough product impact assessment.
This is a 1st shift position.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities:
Authoring and resolution of deviations, change controls, CAPAs, or documents in order to meet production and product release requirements.
Identification and facilitation of interdepartmental process improvements.
Utilize root cause analysis techniques during deviation investigational process
Work cross-functionally, to develop and implement continuous process improvements
Support production needs and continuous improvement including change control, deviation writing/review, CAPA implementation, and operational optimization.
Write, review, revise and prepare manufacturing documents (BPR, SOP, WI) in accordance with cGMP and regulatory guidelines.
Communicate across multiple groups and levels to obtain consensus in order to facilitate deviation closure
Manage multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of the organization
Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
About You
Basic Qualifications:
High School Diploma and 3+ years’ cGMP experience.
Associates Degree and 2+ years’ cGMP experience
Bachelor’s degree and 1+ years’ cGMP experience
Preferred:
Must have knowledge of continuous improvement techniques and problem-solving skills.
Previous experience working within a production department of a pharmaceutical company preferred.
The candidate must be able to work extended and flexible hours (including weekends) when needed.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale.
Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.