ZipRecruiter is hiring : Scientist - GMP Quality & Technical Writing (Hybrid, Dev

Overview

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.

Responsibilities

• 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.

Qualifications

Bachelor’s or Master’s degree in Materials 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.

Familiarity with analytical techniques (FTIR, SEM-EDS, etc.) and data trending / analysis a plus.

Awareness of cGMP regulations and compliance requirements.

Benefits

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