This is a 12 hour shift - 7:00am-7:00pm
Sanofi focuses on rare diseases, multiple sclerosis, oncology, and immunology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. Our approach is shaped by our experience developing highly specialized treatments and forging close relationships with physician and patient communities. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world. Learn more at www.sanofigenzyme.com.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.
The Purification Operation Department performs multi-stage large scale chromatography, tangential flow filtration operations, cleaning and sterilization of process equipment, final formulation operations, and/or preparation of bulk product for shipment as part of a 24/7 large-scale therapeutic protein manufacturing facility.
This is a 12 hour rotating position in a large scale cGMP protein purification facility which includes buffer preparation, CIP of process equipment and preparation/operation of UF/DF and Chromatography systems.
· Practices and promotes safe work habits and adheres to Sanofi’s safety
procedures and guidelines.
· Effectively demonstrates understanding of GMPs and how they apply to specific
· Follows verbal and written procedures in operating production equipment and
performing processing steps; accurately completes appropriate production
· Identifies, escalates and documents events and subtle variances that deviate
from normal operation; participate as needed in investigations.
· Maintains cleanliness and orderliness of process area.
· Maintains production area with supplies.
· Prepares and operates large scale chromatography systems and TFF operations,
and/or buffer preparation operations.
· Performs clean in place operations to prepare equipment for manufacturing
· Performs batch record review, procedure revisions, and work order generation.
· May be responsible for training less experienced or new operators.
· May be designated as a lead operator on manufacturing operations.
· Utilizes manufacturing knowledge to improve process operations and affect
· Demonstrates ability to troubleshoot basic mechanical operations.
· Effectively utilizes Microsoft office applications.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
• High school diploma/GED with 2+ years in a cGMP manufacturing environment
• Associates degree with 1+ years of experience in a cGMP environment
• Bachelor’s degree with no prior experience.
Familiarity with Manufacturing Control Systems (i.e. DeltaV).
Extended experience in large-scale purification operations.
Experience in a GXP environment.
Experience facilitating and delivering training.
Experience creating controlled documents.
Experience in column packing and qualification.
Experience in Lean manufacturing and MDI (management for daily improvement) participation.
SPECIAL WORKING CONDITIONS:
Ability to lift up to 50 lbs.
Ability to stand on average 10 hours per shift.
Ability to gown and gain entry to manufacturing areas.
Ability to work a twelve hour rotating shift and every other weekend, including scheduled holidays.
Ability to work in a cold room environment (2-10 degrees C).
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.
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.