Location
Framingham, MA | United States
Job description
DEPARTMENT DESCRIPTION:
The Process Engineer III position is part of the Upstream Manufacturing Science team in the Recombinant Drug Substance function within global Manufacturing Sciences, Analytics, & Technology (MSAT) and is based at the Mammalian Platform hub in Framingham, MA. The MSAT mission is to enable the reliable supply of medicines by providing expert technical and scientific support for their licensure, ongoing commercial manufacturing, and life-cycle management activities.
Join our global network that contributes to the launch of 3 to 5 new products annually across various modalities and an expansive portfolio, enabling us to reach and serve more patients and communities. Collaborate with a team of talented and passionate international experts, scientists, and project leaders who are dedicated to inventing, designing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modelling, all in support of Sanofi’s best-in-class ambition.
The Recombinant Drug Substance function within global MSAT is the owner of Life Cycle Management (LCM) of DS processes. Implementation of second-generation processes is one of the top performance enablers for Sanofi’s biologics manufacturing network and integral to LCM. We deliver innovative, robust, and cost-effective next generation processes. In recent years we have successfully established second-generation manufacturing mammalian processes with a continuous process platform and developed a robust fed-batch platform for large scale manufacturing. The function is responsible for tech transfer, process validation, dossier preparation, & PAI support to enable launch of new and LCM products. We are pursuing future innovations such as digital labs, factory of the future, and advanced-analytics-based process understanding and control.
POSITION OVERVIEW / KEY RESPONSIBILITIES:
The Process Engineer III works in the Manufacturing Science group to drive the introduction of new products into the 8 New York Avenue Biologics facility. This includes, but is not limited to, planning and execution of validation programs, process troubleshooting, raw material evaluation, continuous process monitoring and improvement. It will be key to interface with the technical transfer sending units to assure a successful transfer of the new product. This person is also responsible for analyzing and drawing accurate conclusions and recommendations from the process and experimental data.
Provide technical and logistical support to GMP operations in a multi-product cell culture and purification plant.
Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.
Develop process knowledge and ownership.
Perform process monitoring using a variety of data analysis methods and techniques (e.g., excel, JMP, etc.).
Provide technical support and analysis for the resolution of deviations, investigations and process issues.
Identify, own and resolve process issues proactively.
Lead the proposal, initiation, testing and implementation of proposed changes to the process.
Complete technical investigations and provides technical expertise.
Generate documents (technical memos and reports, protocols, etc.,) related to tech transfer of new processes.
Participate in cross functional initiatives.
* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
BASIC QUALIFICATIONS:
A Bachelor’s of Science in Chemical Engineering / Biotechnology / Biological Sciences with 5 years of experience in a cGMP manufacturing environment OR
A Masters in Chemical Engineering / Biotechnology / Biological Sciences with 3 years of relevant experience in a cGMP manufacturing environment OR
A PhD in Chemical Engineering / Biotechnology / Biological Sciences with 0-1 years of relevant experience in a cGMP manufacturing environment
PREFERRED QUALIFICATIONS:
Process Validation Experience. Understand cGMP concept and familiar with quality and regulatory framework.
Experience in working with cross functional teams in high paced environment. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.
Strong presentation skills and strong communication and technical writing skills. Experience communicating with business partners and senior management.
Experience with upstream process development.
Proficient in process data analytics. Solid understanding of computerized systems in biopharmaceutical manufacturing environment, i.e., LIMS, Distributed Control System, Process Data Historian, and MES.
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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