Manufacturing Associate

Sanofi Framingham , MA 01702

Posted 3 weeks ago

12-hour rotating day shift position including rotating holidays and weekends as per business needs

WHERE WE ARE:

Our Framingham facility is located within a suburban community about 20 miles west of Boston in beautiful affordable Central Massachusetts with convenient highway access, free on-campus parking, and available shuttle service.

Our campus complex currently incorporates thirteen buildings as part of our R&D and Manufacturing Operations. Sanofi recently completed a multi-year capital expansion with several buildings constructed using "green" technology and resources including the 8 New York Avenue location which was recently heralded as the International Society Process Engineers (ISPE) Factory of the Year.

WHO WE ARE:

Sanofi 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 compassion and commitment of our employees. 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 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 and emerging markets.

DEPARTMENT SUMMARY:

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.

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 adhere 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 that deviate from normal operation; participate as needed in investigations.

  • Maintains cleanliness and orderliness of process area.

  • Stocks 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 operations.

  • Assists in the creation and revision of manufacturing documentation by providing input to technical composition of document.

  • Identifies and assists with troubleshooting routine issues and defects.

  • May be responsible for training less experienced or new operators.

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

  • Effectively utilizes Microsoft Office applications.

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 3-5 years of experience in cGXP manufacturing environment, or Bachelor's degree with 1-3 years of experience.

PREFERRED QUALIFICATIONS:

  • 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 (some site requires changing into scrubs).

  • Ability to work a twelve-hour rotating shift and every other weekend, including some 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.

#GD-SG

#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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