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Process Engineer III, Downstream Job at Sanofi Genzyme at Sanofi

Location Westborough, Massachusetts Job Category Sanofi Genzyme Requisition Number POS_75092849-1
Process Engineer III, Downstream-POS_75092849-1


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:


The Process Engineer III position is part of Process Science in Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Boston. Global MSAT function within Specialty Care Operations (SCO) assures robustness and economics of cell-culture based manufacturing process in support SCO products Life Cycle Management Strategy (LCM) by

· Driving next generation LCM process development and support key SCO strategic initiatives

· Leading Tech transfer, scale-up development and adaptation, control strategy implementation, process validation, comparability for SCO products introduction at Sanofi and external Industrial sites

· Owning process control strategy of licensed products and providing technical assistance and partnership to commercial manufacturing and QC at Sanofi and external sites including change assessment, process monitoring, troubleshooting and continuous improvement for drug substance

MSAT-Process Science is the process owner of all industrial manufacturing processes, analytical methods and associated process control strategies for antibodies and antibody-like molecules expressed from mammalian systems.
POSITION OVERVIEW/KEY RESPONSIBILITIES*:

Process Engineer III will apply her/his solid understanding of engineering principles and professional practices to contribute to MSAT-Process Science mission by performing following duties in one of the Process Science areas:

· Partners with development and manufacturing site teams in process data analysis & process mapping to identify risks and opportunities for process improvements

· Partners with other functions to apply modeling tools to scale-up and scale-down manufacturing processes in support of lab to commercial scale development and validations studies

· Contribute to identification of novel process technology and PAT tools and performs evaluation in support of next generation manufacturing process

· Prepares User Requirement documents and supports engineering function in definition of functional specification followed by C&Q for specific unit operations

· May be a team member of LCM project or Tech Transfer team in support of process design, process control strategy and process validation for next generation process for one of the process science area

· Contributes to training and know-how transfers to manufacturing teams

· May act as MSAT lead for shop-floor support during execution of process development and qualification studies at different scales in one of the Process Science area

· Contribute to technical investigations of complex deviations in manufacturing

· Utilize expertise in engineering and technology management to contributes to design, set-up, maintain and evolve laboratory, and MSAT tools/systems and overall lab performance management systems

· Facilitate harmonization and standardization of process characterization, performance qualification best practices and its implementation for next generation process

· Collaborate with other scientists/engineers across the MSAT, Development and Manufacturing groups

· Present data and results within department and project teams

· Work is performed with minimal supervision and direction. Participates in determining objectives of assignment. Independently determines and develops approach to solution. Work is reviewed for soundness of judgment and overall adequacy and accuracy.

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


Qualifications
BASIC QUALIFICATIONS:

§ Degree in engineering, engineering management or other relevant discipline

AND

§ BS and 8 years of professional experience

OR

§ MS and 6 years of professional experience

OR

§ PhD and 2 years of professional experience

PREFERRED QUALIFICATIONS:

• Hands-on experience at Laboratory, pilot or manufacturing scale for biological products

• Strong skills in data analytics and modeling methods and relevant software

• Strong experience in one or more areas of process development, process transfer, process scale-up and validation activities

• Good knowledge of use of structured methodologies for in one of the areas linked to upstream and/or downstream process design, scale-down model, process control strategies, scale-up, validation and continuous process verification as applied to mammalian-expressed proteins

• Solid understanding GMP commercial biologic manufacturing operations

• Some experience of working in a team environment with other technical staff

• Excellent scientific background and presentations skills

• Highly motivated individual with the ability to work independently as well as on a cross-functional and cross-site teams
LEADERSHIP QUALIFICATIONS:

• Strives for results – sets ambitious tangible and measurable targets ; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets

• Cooperates transversally – Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organization

• Commit to customers- Shares relevant information openly and seeks appropriate input from others outside of the direct team; develops and maintains effective cross-functional working relationships and partnerships; responds positively and constructively to requests for support from across the organization

• Act for Change – Creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes #LI-GZ


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


Job Posting : Feb 24, 2017, 5:52:56 PM

Job Type : Regular
Employee Status : Regular