Sanofi Group Process Engineer II in Westborough, Massachusetts

DEPARTMENT DESCRIPTION:

The External Manufacturing Science and Technology (MSAT) group supports Sanofi products manufactured at Contract Manufacturing Organizations (CMO’s). The group is the keeper of the body of manufacturing process knowledge and ensures manufacturing operations stay aligned with the registered process at each CMO. MSAT is responsible for:

Providing on-site technical support at the CMO as needed.

Supporting and leading process Technology Transfers into CMO sites

Providing technical leadership in process‐related investigations.

Overseeing data management & monitoring/SPC review processes.

Developing strategy for process validation activities.

Identifying and implementing commercial process/product life cycle improvements.

The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved.

POSITION OVERVIEW / KEY RESPONSIBILITIES*:

The External Manufacturing MSAT group is seeking a qualified candidate to fill a purification technical support role for its contract manufacturing organization (CMO). The individual will work with a cross-functional team (QA, Validation, Supply Chain) to establish and ensure an uninterrupted product supply for multiple key products manufactured at CMO’s. The position will be based on the Westborough campus and will require periodic travel to CMO facilities in the US and abroad.

Specific responsibilities include the following*:

Provides technical support for the design, scale-up, optimization, monitoring, and/or operation of the established manufacturing process validated at the CMO.

Support transfer and validation of purification operations into CMO’s, including on-site support, process improvement initiatives, and deviation resolution

Track and trend key process inputs and yields to determine opportunities to improve process yields. Present data at quarterly business reviews.

Implement process improvement opportunities.

Ensure compliance to Sanofi Corporate standards and cGMP’s

Provide on-site support at CMO’s. This includes resolution of manufacturing exceptions and implementation of approved CAPA.

Support regulatory submissions related to the CMO tech transfer.

Codify process knowledge relevant to the manufacturing processes employed at the CMO.

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

BASIC QUALIFICATIONS:

Degree in engineering, engineering management or other relevant discipline

BS and 5+ years of professional experience or MS and 3+ years of professional experience in a manufacturing environment (cGMP) for purification with specific knowledge of key unit operations including chromatography, viral filtration, and ultrafiltration / diafiltration.

PREFERRED QUALIFICATIONS:

Ability to work independently in a CMO environment and to support multiple projects and activities.

Experience with deviation resolution and CAPA implementation.

Experience with on-site support of drug substance manufacturing operations.

Demonstrated success with execution and close out of process improvement studies.

Excellent written and verbal skills and demonstrated ability to liaise between internal QC, supply chain and manufacturing disciplines and CMO Contract Manufacturing and Quality functions.

SPECIAL WORKING CONDITIONS:

Domestic and international travel required.

LEAD COMPETENCES:

Strives for results

Cooperates transversally

Commit to customers

Act for Change

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. #LI

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.