Technical Services​/Manufacturing Sciences; TS​/MS – Materials Management

Overview

Our F500 Pharma client is seeking an experienced TS/MS professional to support our client’s Advanced Therapies Materials Management program. This role will focus on material qualification, supplier technical documentation review, and risk assessment activities to ensure compliance with GMP requirements supporting clinical and commercial manufacturing programs. This position requires strong collaboration across internal cross-functional teams and direct communication with external suppliers to ensure quality, compliance, and continuity of supply.

This individual will report into our client’s Principal Materials Scientist for Advanced Therapies.

• Draft and review material supplier technical evaluations, specifications, and risk assessment documentation in accordance with internal GMP procedures
• Perform risk assessments of incoming materials and evaluate supplier documentation to support material qualification activities
• Review internally generated material testing documentation and prepare associated technical evaluations
• Collaborate with suppliers to resolve documentation discrepancies, quality issues, and non-conformances
• Request and assess supplier documentation, including:
• Production records
• Certificates of Analysis (CoA)
• Certificates of Conformance (CoC)
• BSE/TSE statements

• Support material lifecycle management, including drafting, editing, reviewing, and approving material specifications
• Review material qualification protocols and reports and ensure compliance with periodic review requirements
• Upload, categorize, and route executed documents within the Quality Document Management System (QDocs)
• Assist with preparation, revision, review, and routing of procedural documents
• Support chemical hold studies, nitrosamine assessments, human health risk assessments, and component quality history reports
• Ensure all documentation and processes align with GMP and regulatory expectations

• Successful execution of material qualification activities
• Completion of supplier technical evaluations and risk assessments
• Timely generation and review of GMP-compliant documentation
• Support of ongoing TS/MS initiatives aligned with clinical and commercial manufacturing objectives

• Bachelor’s degree in Organic or Inorganic Chemistry, Biochemistry, or related scientific discipline (preferred)
• Minimum 6 years of experience in Manufacturing or Quality Assurance within a GMP-regulated biotech or pharmaceutical environment
• Demonstrated experience with:
  Material qualification, Supplier Quality activities, Risk assessments for raw materials or components
• Working knowledge of: 21 CFR Parts 210/211, ICH Q7, USP , Excipient compendial requirements, Global regulatory expectations (FDA, EMA, Health Canada)
• Experience using Quality Document Management Systems (QDocs) in a regulated environment
• Experience with ERP systems (SAP preferred)
• Strong proficiency with Adobe Acrobat, Microsoft Office, and Smartsheet
• Excellent written and verbal communication skills
• Ability to professionally communicate with external suppliers

ONSITE M-F 8am-5pm EST at our client’s facility in Lebanon, IN.

Estimated

Start Date:

March 23, 2026

Initial Contract Duration through September 18 2026, with potential to extend

“Skills, experience, and other compensable factors will be taken into account when determining pay rate. The pay range provided in this posting is a reflection of a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.”

“W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick me if required by law in the worked-in state/locality.”