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A Range of Possibilities

Senior Manufacturing Associate

date posted 10/14/2020
contract type Full time
job id R2569215
location Massachusetts; Framingham, Massachusetts

**12-hour day shift positions- including rotating holidays, weekends, and overtime as per business needs**

**Upstream**

Sanofi 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.  Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. Sanofi 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, and animal health.

Position Summary

The Upstream Manufacturing Department performs small and large scale cell culture operations, harvest filtration and initial capture chromatography steps in a new manufacturing facility. The 24/7 large-scale therapeutic protein manufacturing facility uses single use technology.  The Upstream Department is responsible for all setup, operation and breakdown of equipment associated with cell culture and capture column operations.

This position is responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs. 

Core Responsibilities

  • 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 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.

  • Prepare and operate seed train, bioreactor and chromatography equipment

  • Performs clean in place and steam 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.

LEADERSHIP QUALIFICATIONS

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 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.

BASIC QUALIFICATIONS:

High School Diploma/GED with 5-7 years in cGXP manufacturing environment, or Bachelor’s degree with 3-5 years of experience.

PREFERED QUALIFICATIONS:

  • Bachelor’s degree with 4-6 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 reviewing and creating controlled documents.

  • Experience in leading teams.

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 (8 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 and night shift, as applicable.

  • Ability to work in a cold room environment (2-10 degrees C).

Sanofi 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, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.

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#LI-GZ 

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.

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