Scientist

Location: Devens, MA • Duration: 12 months • Pay range: $70–$75.21/hr (W2) • Hybrid: 50% onsite (Tue–Thu); first month fully onsite • Core hours: 9:00 AM–4:00 PM, 40 hrs/wk

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. The successful candidate will collaborate closely with Manufacturing, Manufacturing Technology, Quality Assurance, Quality Control, Supply Chain, and Global Procurement on cross-functional teams.

Responsibilities

• Qualify alternative raw-material suppliers:
  • Work with Procurement to identify new suppliers.
  • Recommend and/or lead testing to qualify material for GMP manufacturing.
  • Author technical equivalency assessments, specification comparisons, and material-characterization reports.
  • Support risk assessments and author change controls.
• Support material and consumable manufacturing investigations.
• Evaluate and manage 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 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.
• Bio-pharma experience preferred.
• Project management in fast-paced environments and ability to manage multiple projects simultaneously.
• Independent contributor comfortable working with multiple stakeholders.
• Change-control experience, preferably in GMP environments.
• Investigation experience.

Schedule

• 40 hours per week.
• Core hours: 9:00 AM–4:00 PM.
• Hybrid: 50% onsite (Tuesday, Wednesday, Thursday); first month fully onsite.

Pay

$70–$75.21 per hour (W2).

Additional information

• No travel required.
• No physical requirements.
• Laboratory work without blood or animal handling.