Materials and Cryogenics Scientist

Onsite/hybrid: 50% onsite (Tue, Wed, Thurs). First month will need to be onsite every day.
Work hours: 40 hours, Core hours are 9:00 - 4:00
Top 3 to 5 Skills or Must haves:
• Demonstrated Technical Writing Ability.
• Worked in Cross matrix Teams.
• Project Management - fast paced environment and can manage multiple projects at once.
• Independent Contributor - personable and can work with multip
...
le stakeholders.
• Change Controls - GMP environments preferred.
• Investigation Experience.
• Bio Pharma experience preferred.
Description:
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.
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.
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
Travel requirements: No
Physical requirements: No
Additional Job Requirements:
• Lab w/o blood & animal

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