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Sanofi Group Process Engineer II in Framingham, Massachusetts

The drug substance function within global Manufacturing Science & Technology (MSAT) is the owner of Life Cycle Management (LCM) of DS Processes within the Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next-generation processes and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, preparing dossier sections, & PAI support to enable the launch of new and LCM products. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting the launch of 20 new products in the next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate, synthorins, and nanobodies. In recent years we have successfully established a second-generation manufacturing process with a continuous process platform. We are pursuing future innovations such as digital labs, factories of the future, and advanced analytics-based process understanding and control.

KEY RESPONSIBILITIES

The successful candidate will work with a group of scientists and engineers responsible for the support of commercial mammalian cell culture processes to a diverse network of manufacturing facilities at external partners. Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs.

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

  • Represent Upstream team as an SME or technical lead in cross-site, cross-functional teams.

  • Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.

  • Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments

  • Oversees and reports on overall manufacturing progress.

  • Designs and conducts necessary experiments to interpret results.

  • May provide technical guidance to less experienced staff.

  • May lead small technical project teams and implement project plans.

  • May lead technology transfer efforts of small project teams between groups/organizations.

KEY RESPONSIBILITIES

The successful candidate will work with a group of scientists and engineers responsible for the support of commercial mammalian cell culture processes to a diverse network of manufacturing facilities at external partners. Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs.

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

  • Represent Upstream team as an SME or technical lead in cross-site, cross-functional teams.

  • Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.

  • Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments

  • Oversees and reports on overall manufacturing progress.

  • Designs and conducts necessary experiments to interpret results.

  • May provide technical guidance to less experienced staff.

  • May lead small technical project teams and implement project plans.

  • May lead technology transfer efforts of small project teams between groups/organizations.

BASIC QUALIFICATIONS:

  • Bachelor’s degree in engineering or science with 3 years of industry experience OR

  • Master’s degree in engineering or science with 1 year of industry experience AND

  • Experience in biotechnology or the pharmaceutical industry

  • Experience in purification, cell culture, or analytical methods

  • Experience in biologics development, bioprocess engineering, technology transfer, and/or commercial manufacturing operations

SKILLS AND COMPETENCIES:

  • Experience communicating with cross-functional teams

  • Strong technical writing and communication skills

  • Proficient in Microsoft Word, Excel, and PowerPoint

SPECIAL WORKING CONDITIONS:

  • Ability to gown and gain entry to manufacturing areas

  • Ability to travel domestically (up to 20% of the time)

PREFERRED QUALIFICATIONS:

  • Familiarity with root cause analysis and/or risk assessment

  • Knowledge of DeltaV automation

  • Experience working with statistical analysis software

  • Experience with project leadership

  • ​Experience with investigative data analysis

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.

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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