Technical Writer (Method development/validation/transfer)

Details for the position are as follows:

• 6-month contract to start with the possibility of extension or conversion depending on performance and budget.
• Location: Lexington, MA – 100% onsite.
• Rate: $56-76 an hour depending on experience level.

Job Description:

We are seeking a dedicated and detail-oriented Technical Writer to support Quality Control (QC) analytical methods functions within our method validation and method transfer projects for biologics. This role involves creating, reviewing, and revising technical documentation critical to QC release and stability testing. The ideal candidate will have a strong background in quality control and regulatory documentation, excellent data analysis skills, and hands-on experience in QC laboratory testing.

Documentation & Authoring:

• Develop and maintain analytical method support documentation for QC release and stability testing of biologics.
• Author comprehensive method validation protocols and reports to facilitate technology transfers.
• Ensure all documentation aligns with ICH, FDA, and EMA regulatory standards.

Analytical Methodologies Support:

• Support QC analytical methods focused on assessing potency, impurities, content, and identity attributes in biologics, including recombinant proteins, antibodies, ADCs, fusion proteins, enzymes, etc.
• Provide expertise in assays such as cell-based assays, residual ProteinA, host cell protein, residual DNA, and protein determination.

Compliance & Data Management:

• Utilize electronic laboratory notebooks and electronic data storage systems to maintain precise and compliant records.
• Document periodic assay trends to ensure compliance and drive operational efficiency.
• Engage with LIMS and Empower software platforms for effective data management.

Collaboration & Communication:

• Work independently in a designated author role while collaborating with QC and Regulatory teams.
• Communicate effectively with internal teams and external partners to support method validation projects.

Required Skills:

• Proven independent technical writing skills within QC and regulatory departments.
• Expert knowledge in data analysis and its application in method validation and technology transfer.
• Hands-on experience in QC laboratory testing is a plus.