Scientist - GMP Quality & Technical Writing (Hybrid, Devens MA)
We are seeking a Scientist to join our client’s Manufacturing Sciences & Technology team in Devens, MA. This role supports the Materials and Cryogenics Science group in the life cycle management of raw materials, consumables, and single-use systems used in biopharmaceutical commercial manufacturing.
You will collaborate closely with Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Procurement on cross-functional teams to ensure GMP compliance and continuity of supply.
Key responsibilities include:
- Qualify alternative raw material suppliers and partner with Procurement to identify new options.
- Recommend and lead necessary testing to qualify materials for GMP manufacturing.
- Author technical equivalency assessments, specification comparisons, material characterization reports, and change controls.
- Support material and consumable manufacturing investigations.
- Manage supplier change notifications and evaluate risks to maintain GMP compliance.
- Contribute to risk assessments and material specification development.
- Partner with cross-functional teams to deliver results in a fast-paced, matrixed environment.
Requirements
Bachelor’s or Master’s degree in Material Science Engineering, Chemistry, or related field with 2+ years of industry experience , or a PhD.
Strong technical writing skills and ability to author GMP documentation.
Experience in cross-matrix team environments and stakeholder collaboration.
Proven ability to manage multiple projects in a fast-paced setting.
Independent contributor with strong communication and interpersonal skills.
Experience with GMP change controls and investigations preferred.
Familiarity with analytical techniques (FTIR, SEM-EDS, etc.) and data trending/analysis a plus.
Awareness of cGMP regulations and compliance requirements.
Benefits
Competitive hourly rate: $67.20 – $75.20/hr (W-2 only, no C2C)
Hybrid schedule (50% onsite Tue–Thu; full onsite during the first month)
12-month contract with possible extension
Health benefits, holiday pay, and 401(k) program
Paid time off (UTO) and professional development support
Employee referral bonus program
Opportunity to contribute to high-impact projects with a leading biopharma company
Recommended Jobs
School Nutritional Aide - Part time
Nutritional Aide Job Description Worcester Cultural Academy is looking to hire a part time Nutrition Aide to support our students and staff. The Nutrition Aide will report to the Nutrition Direct…
Program Facilitator
Youth Development: Program Facilitator, School Programs Come grow with us! Girls Inc. of the Valley is expanding, and we are seeking creative, energetic individuals who are enthusiastic about ins…
Quality Engineer
Roles & Responsibilities Description: Quality Engineer Role ***Looking for Class II Medical Device experience performing Design Transfer activities per FDA CFR 820. Primary responsibilities w…
Director Process Improvement System
POSITION SUMMARY: Reporting directly to the Executive Director, Revenue Cycle Transformation, the Director, Process Improvement - System is responsible for providing the enterprise revenue cycle…
Principal Cyber Tool and Capability Developer
Overview: Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of…
Project Manager
Job Responsibilities: Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management. Reviews sta…
Hotline Center Supervisor (Flexible Part-Time)
Hotline Center Supervisor (Flexible Part-Time) Make a Real Impact Every Weekend We’re urgently hiring a Hotline Center Supervisor to support our mental health crisis line on weekends. This part…
Technical Business Lead - Proactive Service (Remote)
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individu…