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Process Engineer Senior Job at Laboratory at Sanofi

Location Westborough, Massachusetts Job Category Laboratory Requisition Number POS_75054497-1
Process Engineer Senior-POS_75054497-1


Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.

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, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.

DEPARTMENT DESCRIPTION:

The Senior Process Engineer 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 RESPONSIBILTIES*:

Senior Process Engineer 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

· Facilitates cross-functional team of manufacturing, development and other MSAT functions in identification of risks and opportunities for process improvements for next generation process in one of the process science areas

· Leads identification of novel process technologies and PAT tools and performs evaluation in support of next generation manufacturing process design

· May lead definition of lab to commercial scale development and validations studies and execution plan by application of engineering skills and available tools in partnership with other MSAT & development functions

· Participate as 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 areas

· Work collaboratively with Process Science lab heads in upstream, downstream and support service areas for studies execution according to integrated schedule established by project team

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

· Contribute to internal documentation and preparation of reports required for regulatory documents

· Maintains familiarity with industrial and regulatory standards, practices and technology focused on the full range of upstream or downstream process and ways of performing lab studies

· Act as MSAT lead for shop-floor support for know-how transfer and for execution of process development and qualification studies at different scales

· Facilitates 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

· May lead a small project team or task force in support of MSAT mission

· Works independently with little or no supervision. Independently determines technical objectives aligned with overall project objectives and develops approach to solutions in one of the Process Science areas.

* 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 10 years of professional experience

OR

§ MS and 8 years of professional experience

OR

§ PhD and 6 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

• Strong 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

• Strong 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 : Mar 22, 2017, 5:57:06 PM

Job Type : Regular
Employee Status : Regular