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Pharma Tech Unit Leader, Swiftwater, PA

This position, Deputy Director Pharma Tech Unit Leader, within the Manufacturing Technology (MTech) function of Vaccines Industrial Affairs (VIA), will support the delivery of robust and efficient processes and technology for Formulation, Filling, Lyophilization and Inspection processes with emphasis on Flu and other Lyophilized Drug Products.? The mission of the MTech function is to deliver robust and efficient processes with associated knowledge to transfer to Manufacturing. The MTech function also provides daily support to manufacturing toward industrial performance excellence.? The individual in this position will:

  • Drive the technical strategy and project deliverables across the Pharmaceutical Technology landscape for multiple projects across the Swiftwater site
  • Serve as a Subject Matter Expert (SME) for general pharmaceutical technologies, transfers and change management implementation with emphasis on Flu and Lyophilized Drug Products
  • Comply with cGMP and other internal and external quality and regulatory guidance, as well as health and safety guidelines

ACCOUNTABILITIES:

  • Management of the performance of direct reports including 5-10 internal employees through regular coaching and development through strategic assignment of responsibilities
  • Liaison between MTech, Manufacturing, Quality Operations, Project teams, etc. and assist to troubleshoot or resolve any issues that arise
  • Completion of Development, Validation and Transfer of pharmaceutical technologies for release and stability of clinical and commercial products according to project needs and timelines across the Formulation, Filling, Inspection and Packaging (FFIP) platform, balancing technical solutions with operational costs
  • Authoring and reviewing Pharmaceutical Technology procedures, development and validation reports
  • Leadership, within and external to their area of expertise, in the planning, prioritization and execution of development and validation studies to support project (i.e. technical transfer and new vaccine introduction), continuous improvement, and manufacturing assist activities related to Formulation, Filling, Lyophilization, and Inspection

THE JOB RESPONSIBILITIES INCLUDE:

  • Develop and maintain a flexible, trained and agile workforce and provide coaching and developmental opportunities
  • Lead and ensures technical validations and projects related to Formulation, Filling, Lyophilization, and / or Inspection activities are executed on-time and on-budget across the VIA project portfolio in line with business, production and resource constraints
  • Lead and deliver technical solutions for Flu and Lyophilized Drug Products for projects, manufacturing assist and continuous improvement activities?
  • Lead the completion of technical assessments and risk assessments for Flu and Lyophilized Drug Products including Deviations, Change Management and CAPAs

Key Competencies:

  • Model and maintain effective relationships with customers in FFIP and support personnel to be the partner of choice for technical and scientific needs within area of expertise
  • Effectively communicate study outcomes and project impacts to all levels of site leadership and global representatives
  • Lead proactive and strong collaboration internally and across VIA functions in forward thinking with an attitude of optimization and continuous improvement
  • Proactively anticipate and effectively communicate constraints, conflicts, solutions and actions for resolution
  • Collaborate cross functionally with project management groups and? the Pharmaceutical Technology Leadership team to align priorities and platform staffing forecasts

Basic Qualifications:

  • Minimum Bachelors in science or engineering
  • 10+ years? experience in biologics for drug product formulation and filling processes
  • Minimum of 3 years? experience in a Supervisory role managing people

Preferred Qualification:

  • Masters in engineering or sciences

The successful candidate will possess the following additional competencies:

  • Define and balance strategic priorities against immediate operational challenges
  • Learns ? and provides opportunities for others to learn ? from experience
  • Empowers teams to face challenges, make decisions and take action
  • Actively seeks customer opportunities for improvement and to gain insight to underlying needs
  • Creatively challenges the status quo to find new ways of working

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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