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Senior Process Engineer Job at Laboratory at Sanofi

Location Framingham, Massachusetts Job Category Laboratory Requisition Number POS_00471310-11
Senior Process Engineer-POS_00471310-11


Description
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Genzyme Corporation (a Sanofi company) 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.

DEPARTMENT DESCRIPTION:

Manufacturing Science and Technology (MSAT) is the keeper of the body of manufacturing process knowledge, supports the creation of the instruction set and ensures manufacturing operations stay aligned with the registered process. MSAT provides technical and logistical support to Framingham biologics manufacturing facilities. The primary objective is to ensure manufacturing processes are in control, capable, compliant and continuously improved.

MSAT is responsible for:

• Providing technical leadership in process-related investigations

· Providing on the floor technical support and troubleshooting

• Developing strategy for process validation activities

• Provide input to the Process Control Strategy and Operational Control Strategy

• Identifying and implementing commercial process/product life cycle improvements

• Defining relevant operational/technical standards and practices for the site

• Identifying and driving implementation of improvements to maximize throughput and capacity utilization

• Lead the proposal, initiation, testing and implementation of minor proposed changes to purification processes.

• Develop, transfer and maintain robust scale down models to support manufacturing operations

• Utilize this knowledge to effectively support root cause analysis, process validation, implementation of process improvements, and improvements in process control strategies.

POSITION OVERVIEW / KEY RESPONSIBILITIES*:

The Senior Process Engineer works in the Manufacturing Science and Technology (MSAT) department to provide expert technical support to Commercial Cell Culture and Purification Operations at the Framingham Biologics site and lead major technical initiatives. Your technical expertise and professional practices will be used to:

Establish technical support initiatives for GMP operations in a multi-product cell culture and purification facility.
Network with Manufacturing and Quality organizations to establish a reliable state of process control.
Maintain process knowledge and ownership.
Lead the proposal, initiation, testing and implementation of changes to cell culture or purification processes.
Lead and manage cross functional teams to drive major technical projects and initiatives.
Develop advanced process monitoring programs using a variety of data analysis methods and techniques including multivariate methods.
Develop technical strategies and lead scale down studies to provide a science-based approach for the resolution of deviations, investigations and process issues.
Establish continuous improvement strategies.
Develop strategies for maintaining inspection readiness of the site.
Establish and participate in cross-functional initiatives.
Generate documents (technical memos, protocols, reports, etc.) related to process monitoring programs, scale down studies, annual product reviews and non‑conformances.

Qualifications
BASIC QUALIFICATIONS:

• Degree in life sciences, engineering or other relevant degree

• BS with 10+ years or Masters with 8+ years or PhD with 6 years of experience

• At least 3 years of experience in a cGMP manufacturing environment or biologics process development.
Experience leading projects and cross-functional initiatives

PREFERRED QUALIFICATIONS:

Extensive experience in the scale up and operation of large scale biotechnology processes.

Hands on experience with large scale biotechnology unit operations.

• Bio-process development experience is highly desirable.

In-depth understanding of large scale biotechnology unit operations, principles of biochemical engineering, and process data analysis.

Demonstrated ability to lead technical projects and small teams.

Full understanding of compliance and cGMP considerations.

Demonstrated commitment to continuous improvement – at the individual, department and organizational level. #GZ-LI


Job : Laboratory/Process/Device Development
Primary Location : United States-Massachusetts-Framingham


Job Posting : Feb 17, 2017, 12:40:31 AM

Job Type : Regular
Employee Status : Regular