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Associate Director Manufacturing and Technical Services

date posted 04/02/2021
contract type Full time
job id R2592952
location Ridgefield, New Jersey

POSITION OVERVIEW

Job Title: Associate Director Manufacturing and Technical Services

Key Responsibilities

  • Lead the Manufacturing and Technical Services Department at the Ridgefield site. 

  • This hands-on position will provide input to industrialization strategies and rationale for critical process parameters.

  • Subject Matter Expert (SME) for process development and process engineering studies for the site.

  • Responsible for process design and continuous improvements, support execution and documentation of development and/or process engineering studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition and process engineering runs.

  • Document and interpret study results with recommendations.

  • Provide technical leadership as a subject matter expert in multiple areas of responsibility including leachable and extractables studies, technology transfers and new material evaluations.

  • Partner with engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment.

  • Provide technical assistance to manufacturing and quality operations for process troubleshooting, health authority inspections and achieving site metrics (+QDCI). 

  • Proficient with structured methodologies such as  GMP’s, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, engineering and control.

  • Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.

  • Experience in equipment start-up, aseptic manufacturing, filtration and sterilization is required.

  • Responsibilities will have direct reports.

Requirements:

  • Bachelor's Degree/Undergraduate Degree required with Advanced Degree in pharmaceutical engineering or sciences preferred.  

  • Minimum of 12 Years experience in pharmaceutical industry, process development, and/or process engineering.

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.

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