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
Lead the execution and scale-up of downstream purification manufacturing, from 50-L pilot through 2000-L scale, partnering with CMC project teams on logistical planning for pre-clinical manufacturing campaigns
Lead the authoring, review, and revision of SOPs, batch records, and batch reports for pilot and large-scale downstream operations
Perform data analyses supporting pilot and large-scale DSP manufacturing, and contribute to technical reports and internal/external presentations
Lead troubleshooting of manufacturing issues and communicate findings to appropriate working groups
Maintain critical process equipment and consumables to minimize downtime, and lead or support evaluation of new process technologies to improve yield, cost, and cycle times
Support digital transformation and continuous improvement initiatives within GMU CMC (e.g., electronic batch records, process data capture, workflow enhancements)
Develop and maintain advanced knowledge of column chromatography, filtration, and related purification technologies; mentor junior staff and foster a collaborative team culture
About You
Education
Master’s degree in chemical or biochemical engineering or related disciplines with a minimum of 2 years of relevant experience or a bachelor’s degree with a minimum of 4 years of relevant experience
Experience & Technical Skills
Significant experience of working with pilot- and large-scale DSP manufacturing unit operations
Significant experience, knowledge, and understanding of purification technologies and operations.
Required: Hands-on experience with Chromatography and Tangential Flow Filtration (TFF)
Preferred: Experience with Depth Filtration and/or Viral Filtration/Inactivation.
Experience with process technology transfers and performing gap analyses and risk assessments
Expertise in drafting batch records and SOPs (required); experience authoring technical reports (preferred).
Preferred Qualifications
Experience in AAV purification development
Experience in CMC and drug development
Experience with digital solutions to enable efficient manufacturing operations (e.g. electronic batch records, electronic notebooks, etc.). Knowledge of product comparability, target product profile and quality risk assessment activities
Knowledge of basic analytical tools such as UV spectrophotometry and DLS particle sizing
Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)
Soft Skills
Ability to work under minimal supervision and function within a collaborative, team-oriented environment
Excellent organization and communication skills
Ability to communicate and represent group in diverse, multi-functional meetings
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.
Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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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Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.
North America Applicants Only
The salary range for this position is
$85.500,00 - $123.500,00
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.
