Materials and Cryogenics Scientist

Hybrid role: 50% onsite (Tuesday, Wednesday, Thursday). First month will require onsite presence every day. Core working hours are 9:00 AM – 4:00 PM, 40 hours per week.

Top Skills

• Demonstrated technical writing ability
• Experience working in cross-matrix teams
• Project management in fast-paced environments with multiple concurrent projects
• Independent contributor comfortable collaborating with diverse stakeholders
• Change control experience, preferably in GMP environments
• Investigation experience
• Bio/pharma experience preferred

About the Role

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 used in biopharmaceutical 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
• Support material and consumable manufacturing investigations
• Evaluate and manage material-associated supplier change 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)

Additional Information

• No travel requirements
• No physical requirements beyond standard lab work (no blood or animal handling)