Providing collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement
Anticipating, responding to, and permanently resolving issues that arise during production
Aiding in the design of new processes and facilities with expertise in scale-up, manufacturability, PAT, capacity analysis, and cost analysis
Leading the creation and use of digital process data analytic systems
Partnering with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process lifecycle improvements.
Main Responsibilities
Provide technical leadership in area of responsibility; deliver technical/scientific support, expertise, and guidance to manufacturing and quality teams
Lead the design, troubleshooting, and continuous improvement of complex, critical single-use assemblies, such as single-use bioreactor bags, alternating tangential flow devices, nano filtration assemblies, etc., ensuring fit, function, and performance in GMP manufacturing processes.
Ensure a solid understanding of engineering principles and theories in the area of responsibility and apply them to solve a range of complex problems in creative and practical ways
Apply advanced troubleshooting skills for complex manufacturing deviations
Lead complex technical project teams or cross-functional teams between groups and organizations; provide input and coordinate support from process development teams
Review manufacturing processes and/or development and production data to assess process performance and identify opportunities for improvement
Support documentation preparation for regulatory purposes and stay current on regulatory requirements that impact manufacturing processes; evaluate and implement changes as required
Provide CMC support and guidance for product lifecycle management
About You
Basic Qualifications
Bachelor's degree is required. Engineering, science or related disciplines are preferred.
5+ years of relevant experience in the pharmaceutical, biopharmaceutical, or other regulated manufacturing industry (GMP).
Hands-on experience with design, troubleshooting, or continuous improvement of complex critical single-use assemblies.
Preferred Qualifications
Demonstrated expertise applying fundamental principles to real-world problem solving and providing practical solutions to difficult technical issues
Experience with biologics upstream or downstream unit operations with perfusion or continuous operations a plus
Expansive experience leading the design, troubleshooting, and continuous improvement of single use technologies.
Experience with extractable and leachable
Understanding of cGMP concepts and familiarity with quality and regulatory frameworks
Proficiency in process data analytics
Knowledge of computerized systems in biopharmaceutical manufacturing environments (e.g., DeltaV, Process Data Historian, LIMS, MES)
Experience leading projects and/or cross-functional teams
Works independently with minimal supervision and direction; performs work that consistently requires independent decision-making and the exercise of independent judgment and discretion
Ability to navigate ambiguous circumstances to meet final objectives
Strong communication and technical writing skills; experience communicating with business partners and senior management
Technical Skills
Process Data Analytics
Process Validation & Compliance
Biologics Manufacturing Operations
Process Development & Scale-Up
Manufacturing Systems & Tools
Soft Skills
Independent Decision-Making
Cross-Functional Collaboration
Technical Communication
Problem-Solving & Ownership
Mentoring & Leadership
Special Working Conditions
Ability to gown and gain entry to manufacturing areas.
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 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
$100,500.00 - $167,500.00
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.
