Project Manager , External Clinical Manufacturing, Gene Therapy- Framingham/MA

Job description

Job Summary

The Gene Therapy External Clinical Manufacturing group provides technical and operational oversight of manufacturing operations at Sanofi's CMO partners to ensure the GMP manufacture and supply of a diverse, multi-product portfolio of gene therapy products in support of early and late stage clinical development.

The position of Project Manager, External Clinical Manufacturing, Gene Therapy provides support for managing the CMO business relationship and assists in the cross-functional interaction among the internal development and technical teams (Process Development, Analytical Development, Technical Operations and Quality) and the CMO project manager.

Job Duties and Responsibilities

·  Act as primary contact for CMO project manager.
·  Monitor milestones, timelines and deliverables per project plan from CMOs and communicate effectively with key internal stakeholders.
·  Collaborate internally and externally to ensure effective tech transfer to CMOs
·  Facilitate weekly Joint Project Team meetings, advocating internal interests and influencing decision making.
·  Ensure Sanofi and CMO compliance with virus safety and regulations.

Qualifications

Formal Education and Experience

·  BS degree in Engineering, Life Science or Business Administration and 4-6 years of relevant experience.
·  Or (preferred) Master's degree in Engineering, Life Science or Business Administration and 2-4 years of relevant experience.

Knowledge and Skills

·  Experience managing programs at CMO partners.
·  Knowledge of AAV and/or lentivirus gene therapy Drug Substance and Drug Product manufacturing utilizing various technologies, GMP regulations, FDA guidances and project management tools (e.g., MS project Advanced, Think-Cell) are highly desired.
·  Experience with finance and business systems is a plus (e.g., optime, AEDs).
·  Proficiency with Microsoft Office suite.
·  Demonstrate the ability to develop effective working relationships with internal and external partners and cross-functional working teams.
·  Must be team oriented, practicing sound judgement and willingness to take initiative.
·  Ability to identify and resolve problems in a timely manner, seeking expertise internally and externally as needed.
·  Must be organized and possess strong interpersonal skills.
·  Excellent verbal and written communication skills are a must.
·  Ability to travel (U.S./int'l) 10% of time is required.

Sanofi Inc. 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.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.