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- Level: Mid-Senior
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ResponsibilitiesJob ID R74 Date posted 04/10/2017
The External Manufacturing Science and Technology (MSAT) group supports Sanofi specialty care 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 and from 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 and integration of new technologies when applicable.
The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved.
POSITION OVERVIEW / KEY RESPONSIBILITIES*:
The External manufacturing group is seeking an experienced analyst to drive analytical technical transfers from Sanofi (or current analytical site) to selected contract manufacturing organizations (CMO) in a timely and consistent manner and per established internal guidelines. This individual will work in a fast paced, cross-functional team environment and act as the primary liaison for analytical subject matters between Sanofi Specialty Care operations and the selected CMO. The position will be based on the Westborough MA campus and will require periodic travel to CMO facilities in the US and abroad.
The Analytical team member will work with the QC/Analytical Lead and be an integral part of the Tech Transfer Core Team throughout the planning and execution phases for tech transfer of Genzyme’s proprietary downstream processes from an internal manufacturing site to selected CMOs. This person will work with the QC/Analytical Lead to coordinate the technology transfer of analytical methods, ensuring that the requirements of the internal Corporate Quality Standards and relevant regulatory requirements are fully met. They will also interact with the Analytical Life Cycle Management Team, who are focused on maintaining the methods to evolving standards, to ensure alignment of actions between Genzyme and the CMO.
Specific responsibilities include the following:
Working as part of the Tech Transfer Core Team, develop details of the analytical method technical transfer plan including a full plan of execution, timelines, and deliverables. This plan will be based on the general proposal already created by a Genzyme working group and the selected CMO’s and integrated into the overall tech transfer plan.
For assay transfers, provide project management and/or technical guidance for the sending unit (Genzyme), and interact with Genzyme QC groups as an SME.
On behalf of the sending unit collect, review and approve assay-related technical and GMP documents.
Work with the QC/Analytical Lead to provide status updates to the Core Team and the Project Manager and escalate issues when appropriate.
Serve as a QC/Analytical contact with the CMO and work with Analytical Lead and internal groups for resolving issues and potential conflicts.
In collaboration with QC/Analytical lead and CMO Quality, assure that the CMO meets and maintains the requirements and specifications set forth in the tech transfer plan.
Provide continued on-site support at selected CMO. Regular visits to the CMO facilities will be required, particularly as the facility becomes operational for the transferred process. This level of support will include:
Monitoring assay performance
Report, resolve, and escalate analytical discrepancies to ensure continuity in the assay performance.Collaborate with analytical life cycle management team (ALCM) in design and execution of analytical improvement studies.Support regulatory submissions related to the CMO tech transfer and post transfer commitments
Degree in analytical chemistry, life sciences or engineering AND BSc and 10+years of professional experience OR MS and 8 years of professional experience OR PhD and 6 years of professional experience.
5 - 10 years experience and knowledge of current and established protein assay methodology and protein characterization methods.
5+ years experience and knowledge of conventional raw material assay methodologies
General knowledge of setting in-process control limits, release criteria and familiarity with quality control operations.
Working knowledge of US and EMA guidelines for analytical method transfer and understanding of current regulatory expectations.
Ability to work independently in a fast paced environment that is results focused. Individual will routinely update working groups.
Excellent written and verbal skills and demonstrated ability to liaise with internal QC, development and manufacturing disciplines and CMO Quality functions.
SPECIAL WORKING CONDITIONS:
International and domestic travel required.
• 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
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
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