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Deputy Director Drug Substance Engineering & Technology Lead - Vaccine

Swiftwater, Pennsylvania

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Responsibilities

Position Title

Deputy Director Drug Substance Engineering & Technology Lead

Location

Swiftwater, PA

Who We Are

Vaccine Industrial Affairs (VIA), at our Swiftwater, Pennsylvania site, the largest vaccine manufacturing facility in the US, continues to develop its manufacturing assets to produce existing and new vaccines and bio-pharmaceuticals. Sanofi Pasteur provides associates in IA a variety of opportunities to develop and enhance their career through the ability to work in diverse roles across functions, resources for continuous learning, and assistance for those wishing to further their education.

Job overview

The Deputy Director Drug Substance Engineering & Technology Lead, within the Manufacturing Technology (MTech) function of Vaccine Industrial Affairs leads the life-cycle design and industrialization strategy of upstream product processes for Phase 3 and licensed products (new vaccines and bio-pharmaceuticals AND life-cycle improvements) to assure commercialization of robust, compliant, and efficient vaccine and biopharmaceutical manufacturing. The mission of MTech function is to deliver robust and efficient process & testing with associated know how transfer to Manufacturing & QC. MTech function also provides daily support manufacturing and QC toward industrial performance excellence.

Responsibilities

  • Lead the Drug Substance Engineering and Technology team (direct and indirect headcount) to contribute to the development of robust industrial processes through application of engineering principles and technology innovation in support of site LRP.
  • Provide input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
  • Develop process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes.
  • 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, and health authority inspectionsto achieving site metrics (+QDCI).

Basic Qualifications:

  • A Bachelors or Masters degree in basic sciences, math, engineering, or pharmacy with 6+ years’ experience OR PhD with 3+ years’ experience in biological processes or analytics in a cGMP environment.
  • Candidate should possess educational and professional experience, commensurate with the position.
  • Candidates shall have demonstrated experience in the following: Expertise in the design of product process unit operations typically used in production of Drug Substance of bio-pharmaceuticals / vaccines as well as project / engineering lifecycle; Knowledge of computer software common to mission (Auto CAD, process simulation / scheduling, CFD).  The 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.

Preferred Qualifications:

  • BS in Chemical or Biochemical Engineering (or similar) with minimum 10 years industrial experience.
  • Advanced degree in sciences with 15+ years large scale process equipment design, scale-up implementation & validation experience.
  • Experience in equipment start-up, qualification and validation is preferred.
  • Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies employed in the course of industrial process design, validation and control.
  • Leadership and development of technical teams.

Terms of employment:

The Deputy Director Drug Substance Engineering & Technology Lead:

-Recognized as the site expert and point of contact within vaccine drug substance process design and technology.

-Strong global network for the field of expertise, both within Sanofi and outside of Sanofi world-wide.

-Strategic vision on the future of vaccine drug substance processes and its implementation on the Swiftwater site.

-Responsible for coaching and mentoring junior personnel and educating / maintaining technical knowledge in workforce.

-Influences internally and across VIA functions; forward thinking with an attitude of collaboration, optimization, efficiency, continuous improvement.

-Proactively anticipates and effectively communicates successes, constraints, conflicts, solutions and actions for resolution.

-Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate.

-Sensitive to the broader work environment and fosters relationships with partners, experts from other functions and customers in order to achieve technical objectives.

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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