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R and D Manufacturing Associate

Framingham, Massachusetts

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Overview

From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.

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Success Profile

Do you have what it takes for a successful career with Sanofi?

  • Courageous
  • Leadership
  • Proactive
  • Problem-Solver
  • Results-driven
  • Team player

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Culture: Play to Win

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    Growth

  • Scientists discussing lab work

    Innovation

  • Doctor using new technology

    Efficiency

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    Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

POSITION OVERVIEW:

This role is part of the Drug Substance Manufacturing Biologics (DSMB) group focusing on Downstream Processing (DSP). This group is responsible for producing Phase 1 through early Phase 3 clinical drug substance to support first in human and later stage clinical trials. The key accountability for this position is the downstream steps processing harvest from the bioreactor through to drug substance.

He/she Will work with all members of DSMB with potential for cross training.

Schedule is Monday through Friday, first shift. Occasional weekend work may be required.

KEY RESPONSIBILITIES:

  • Perform daily process activities in compliance with standard operating procedures (SOPs).

  • Operate downstream process equipment and operations in compliance with cGMP requirements (current good manufacturing practices).

    • Column chromatography

    • Virus filtration

    • Ultrafiltration/Diafiltration

    • Adjustment of intermediates

  • Prepare equipment and solutions for processing.

  • Complete and review associated production records.

  • Interact with validation, metrology, and facilities groups to ensure equipment is maintained in cGMP status.

  • Prepare and submit samples for QC and other testing to the analytical laboratories.

  • Interact with QA when compliance issues arise.

  • Support activities include maintaining supplies, preparing solutions, setting up and disassembling processing equipment cleaning and maintaining equipment, basic troubleshooting.

BASIC QUALIFICATIONS:

  • High school diploma/GED, Biotechnology certificate with 3-5 years of experience in a cGMP manufacturing environment or a Bachelor's degree or Associate's degree with 1-3 years of experience

  • Knowledge and demonstrated understanding of GMP and how it applies to specific responsibilities and manufacturing operations.

  • The ability to cooperate with others in a team environment will be critical to success.

  • SOP writing

PREFERRED QUALIFICATIONS:

  • Understanding of chromatography, membrane filtration and other unit operations used in protein purification.

  • Proficiency in aseptic technique.

  • Experience using Unicorn AKTA skid or other manufacturing systems.

  • Experience with Athena or similar SAP system.

  • Must be self-motivated, detailed oriented, have good time management skills, be flexible, team oriented, and demonstrate good troubleshooting skills.

SPECIAL WORKING CONDITIONS:

  • Ability to gown and work in clean room environment.

  • Ability to lift 50 pounds.

  • Push/pull up to 50 pounds to move mobile equipment around the process suites.

  • Frequent sitting, walking, standing, bending, and squatting.

  • May require standing and walking up to 70% of day.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. 

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

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PDN

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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