Scientist - GMP Quality & Technical Writing (Hybrid, Devens MA)
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Job Description
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
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.