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Scientist - GMP Quality & Technical Writing (Hybrid, Devens MA)

$67-75/hour

SOKOL GxP Services

Devens, MA, USA

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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

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Location
Devens, MA, USA
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