Scientist
Location : Devens, MA
Hours/Schedule : 40 hours, Core hours are 9:00 - 4:00
Type: Contract
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
The subject matter expert for this position will be primarily required to:
• 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
- 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. Ref: #558-Scientific
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