Sanofi Group Manufacturing Technician Senior, Framingham, MA in Framingham, Massachusetts

DEPARTMENT DESCRIPTION:

The Cell Culture Operations Department performs small and large scale cell culture operations, media preparation, equipment preparation, clean in place (CIP) and steam in place (SIP), and Preventative Maintenance of process equipment as part of a 24/7 large-scale therapeutic protein manufacturing facility.

POSITION OVERVIEW/KEY RESPONSIBILTIES*:

Position Summary

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 safe work habits and adheres to Genzyme’s safety procedures and guidelines.

  • Demonstrates knowledge and understanding of GMPs & 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 that deviate from normal operation; participate as needed in investigations.

  • Maintains cleanliness and orderliness of operational area.

  • Stocks production area with supplies.

  • May perform support function for more senior operators.

  • Interacts with other support functions, such as Quality Assurance, Quality Control, Manufacturing Engineering, MTS, Validation, etc.

  • Utilizes manufacturing knowledge to improve process operations and affect positive change.

Additional Responsibilities

  • Demonstrates general knowledge of mammalian tissue culture processes.

  • Demonstrates general knowledge and practice of aseptic techniques.

  • Provides daily monitoring of seed cultures including sampling and in process assays (cell counting).

  • Cleans and builds equipment for manufacturing use including spinner flasks.

  • Demonstrates general knowledge of mammalian tissue culture processes.

  • Completes tasks in support of large scale cell culture bioreactor operations.

  • Provides daily monitoring of cultures and bioreactor processes including sampling and in process assays (cell counting).

  • Demonstrates general knowledge of aseptic techniques.

  • Performs PM, CIP, and SIP operations to prepare equipment for manufacturing operations.

  • Demonstrates ability to follow detailed instruction set in order to execute production activities.

  • Demonstrates ability to follow detailed instruction set in order to execute production activities.

  • Demonstrates ability to build, clean and sterilize equipment to support Media/Buffer Preparation, Purification and Cell Culture equipment preparation.

  • Demonstrates knowledge of Autoclaves.

  • Demonstrates knowledge of Clean out of Place (COP).

  • Media Preparation:

  • Demonstrates general understanding of gas and liquid filtration.

  • Demonstrates understanding PM, CIP, and SIP operations to prepare equipment for Media Preparation operations.

  • Supports a clean neat work environment.

  • Demonstrates general understanding of application of sanitization practices.

  • Demonstrates ability to measure raw materials and operate basic Benchtop instruments.

* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs

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 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.

BASIC QUALIFICATIONS:

  • 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.

PREFFERED QUALIFICATIONS:

  • Biotech Certificate

  • Effectively uses process automation systems to operate production processes (i.e. DeltaV).

  • Experience in reviewing and creating controlled documents.

  • Familiarity with Deviation Management Systems (i.e. Trackwise).

SPECIAL WORKING CONDITIONS:

  • Ability to lift up to 40 lbs.

  • Ability to stand for 6 hours in a production suite.

  • Ability to gown and gain entry to manufacturing areas.

  • Ability to work a 12 hour rotating shift and every other weekend, including holidays as scheduled.

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.

#GD-GZ

#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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life