Joulé
Overview
The Scientist in Manufacturing Sciences & Technology will support the Materials and Cryogenics Science group in the life cycle management of raw materials, consumables and single-use systems utilized for biopharmaceuticals commercial manufacturing operations. The successful candidate will collaborate closely with Manufacturing, Manufacturing Technology, Quality Assurance, Quality Control, Supply Chain, and Global Procurement groups on cross-functional teams. Responsibilities
Qualify alternative raw material suppliers:
Work with procurement to identify new suppliers Recommend and/or lead necessary testing to qualify material for use in GMP manufacturing Author technical equivalency assessments, specification comparisons and material characterization reports Support risk assessments Author change controls
Additional Tasks would include:
Support material and consumable manufacturing investigations Evaluate and manage material associated supplier changes notifications to maintain GMP compliance. Support material specification development
Requirements
Minimum BS/MS with 2+ years of industry experience post-graduation or PhD in Material Science Engineering, Chemistry or equivalent scientific background. Awareness of cGMP compliance and regulatory agency requirements. Demonstrated problem solving ability (familiarity with root cause analysis techniques and CAPAs a plus) Strong organizational, oral communication and technical writing skills Effective team player and strong individual contributor Familiarity with analytical techniques (FTIR, SEM-EDS, etc.) Knowledge of data trending and tracking, including use of statistical analysis software a plus Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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The Scientist in Manufacturing Sciences & Technology will support the Materials and Cryogenics Science group in the life cycle management of raw materials, consumables and single-use systems utilized for biopharmaceuticals commercial manufacturing operations. The successful candidate will collaborate closely with Manufacturing, Manufacturing Technology, Quality Assurance, Quality Control, Supply Chain, and Global Procurement groups on cross-functional teams. Responsibilities
Qualify alternative raw material suppliers:
Work with procurement to identify new suppliers Recommend and/or lead necessary testing to qualify material for use in GMP manufacturing Author technical equivalency assessments, specification comparisons and material characterization reports Support risk assessments Author change controls
Additional Tasks would include:
Support material and consumable manufacturing investigations Evaluate and manage material associated supplier changes notifications to maintain GMP compliance. Support material specification development
Requirements
Minimum BS/MS with 2+ years of industry experience post-graduation or PhD in Material Science Engineering, Chemistry or equivalent scientific background. Awareness of cGMP compliance and regulatory agency requirements. Demonstrated problem solving ability (familiarity with root cause analysis techniques and CAPAs a plus) Strong organizational, oral communication and technical writing skills Effective team player and strong individual contributor Familiarity with analytical techniques (FTIR, SEM-EDS, etc.) Knowledge of data trending and tracking, including use of statistical analysis software a plus Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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