**12-hour day shift positions- including rotating holidays, weekends, and overtime as per business needs**
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
This is a 1st shift 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. Initial job responsibilities will include working with a group of manufacturing personnel responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV).
The Purification Operations 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.
Practices and promotes safe work habits and adheres to Genzyme’s safety procedures and guidelines.
Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.
Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
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.
Ensures production area is stocked 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 operations.
Performs batch record review, procedure revisions, and work order generation.
Fulfills role of lead trainer on numerous operations and is an area SME.
Utilizes manufacturing knowledge to improve process operations and affect positive change.
Demonstrates ability to troubleshoot basic mechanical operations.
Effectively utilizes Microsoft office applications.
Mentors less experienced operators and performs support function for supervisor.
Leads teams to the execution of the daily work plan.
May attend scheduling and MDI meetings in absence of supervisor.
May lead shift handover or act as a shift lead in the absence of a supervisor.
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. This includes:
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 Genzyme 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.
Bachelor’s degree with 2-4 years of experience in bulk biologics cGMP manufacturing.
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 (74 NYA site requires changing into scrubs).
Ability to work a twelve hour rotating shift and every other weekend, including scheduled holidays.
Ability to work day or night shift, as applicable.
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.