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Senior Process Engineer/Manager

Framingham, Massachusetts

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"One of the best things about Sanofi Genzyme is the consistently fun and dynamic work environment that I get to be a part of."

Kristin Ouimet Regional Business Manager

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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

Department Descriptions:

MSAT is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. MSAT ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.

  • Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement

  • Anticipate, respond to, and permanently resolve issues that arise during production.

  • Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.

  • Lead the creation and use of digital process data analytic systems.

  • Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.

Key Responsibilities:

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

The Manager, MSAT is expected to:

  • Lead MSAT support to Thyrogen, Fz-ICB, and Falcon upstream commercial operations.

  • Lead a group of experts/engineers that provide technical/scientific support, expertise, and guidance to manufacturing and quality. Support ongoing development of staff to maximize individual team performance.

  • Utilize a solid understanding of scientific principles and professional practices to solve a range of complex problems in creative and practical ways.

  • Provide input and coordinates support from process development teams. Coordinates with cross functional teams to progress lab studies.

  • Reviews manufacturing processes and/or development and production data.

  • Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.

  • Provide CMC support and guidance for product lifecycle management.

  • Attend development and scientific meetings to remain current with technology and regulatory guidelines. Interact with colleagues from various Sanofi functions in particular Engineering, Science, Manufacturing, Quality, and MSAT functions to meet the group’s goals.

Basic Qualifications:

  • Bachelor’s Degree in engineering or science with 9 years of experience.

  • Master’s degree in engineering or science with 7 years of experience.

  • Ph.D. in engineering or science with 5 years of experience.

Leadership Qualifications:

Build, manage, motivate, and empower teams and workgroups. Take responsibility for developing one’s self and others in anticipation of future business needs.

Preferred Qualifications:

  • Preferred qualifications are additional qualifications or experience that would make an individual ideal for the job. However, if the individual does not have these qualifications, it does not disqualify them from being considered for the job.

  • Strong technical writing skills.

  • Experience with high level data analysis.

  • Experience leading technical teams and leading projects.

  • Experience in biotechnology or the pharmaceutical industry.

  • Experience with large scale cell culture or purification manufacturing.

  • Experience with root cause analysis and/or risk assessment.

  • Experience working with statistical analysis software.

  • Experience with project leadership.

  • Experience communicating with cross functional teams.

  • Experience providing solutions for difficult technical issues.

  • Experience communicating with senior management.

Special Working Conditions:

  • Occasional travel expected.

  • Ability to lift weight.

  • Ability to gown and gain entry to manufacturing areas.

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.

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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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