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Purification Process Scientist – Swiftwater, PA

Sanofi Inc.

This is a Full-time position in Swiftwater, PA posted July 7, 2020.

Location: Swiftwater, PA

Job overview

The Downstream Process Scientist within the Manufacturing Technology (MTECH) department of Vaccine Industrial Affairs leads the design and execution of small-scale development, optimization, and/or troubleshooting studies with high technical and scientific complexity to support the manufacturing and continuous improvement of bacterial polysaccharide and recombinant protein cell culture-based vaccines.

Responsibilities

  • Serves as a subject matter expert (SME) for manufacturing downstream operations, including centrifugation, tangential flow filtration, depth filtration, and column chromatography; purification scale-up/scale-down expertise
  • Provides technical guidance for purification process development and optimization to support projects during process development, technology transfer, and process characterization/optimization of cGMP bacterial polysaccharide and cell culture based recombinant protein vaccines
  • HPLC Chromatography knowledge, responsible for optimizing methods to determine potency, purity, and stability for drug substances (DS) and/or drug products (DP)
  • Leads and supports the design and execution of purification validation studies, including data interpretation and documentation
  • Develop experimental plans to test parameters to optimize yield and quality of biological products and apply statistical based methodologies (i.e. Design of Experiment)
  • Participates in new technology initiative efforts and continuous improvement projects (multi-column chromatography, continuous viral inactivation, single pass TFF)
  • Provides technical support for downstream process related manufacturing deviations, CAPA’s and change controls
  • Develops and writes technical documents, including technical protocols and reports, process validation documents, memos, and investigations
  • Supports the management of laboratories and equipment
  • Must be familiar with BSL-II lab safety requirements
  • Participate in multi-disciplinary projects, facilitate collaboration with both drug substance analytical, quality control, quality assurance, and manufacturing teams
  • Responsible for coaching and mentoring junior personnel and educating / maintaining technical knowledge in workforce
  • Updates group members on background and status of projects by internal presentations
  • Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate
  • Serve as technical contributor on cross functional teams including Sanofi Pasteur network teams

 

Basic Requirements & Qualifications:

Education/Experience:

  • Minimum Bachelors degree required (basic sciences, math, engineering, or pharmacy) AND 2+ years’ experience in a similar role.
  • Strong knowledge of column chromatography using automated systems (AKTA)
  • Demonstrated understanding of cGMP process development and production
  • Ability to identify, evaluate, and industrialize new technologies for DSP

OR

  • PhD with experience in biological processes or analytics in a cGMP environment AND
  • Strong knowledge of column chromatography using automated systems (AKTA)
  • Demonstrated understanding of cGMP process development and production
  • Ability to identify, evaluate, and industrialize new technologies for DSP

Preferred Qualifications:

  • Demonstrated history of strong hands-on ability, problem solving, and independent experimental design and execution
  • Ability to adapt to change and effectively deliver under pressure and time constraints, while maintaining a high level of work quality

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.

#GD-SP           

#LI-SP

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.