Job Description

Job Description:

We are seeking a skilled and experienced Scientific/Technical Writer to join our team. The ideal candidate will be responsible for authoring comprehensive analytical methods, protocols, and supporting documentation related to the release and stability testing of biologics.

In this role, the Scientific/Technical Writer will be involved in drafting, reviewing, and finalizing critical documents, such as method validation protocols and reports, to support technology transfers and ensure regulatory compliance. Familiarity with LIMS (Laboratory Information Management Systems) and Empower software platforms is also essential.

Key Responsibilities:

• Write and maintain clear, detailed, and accurate analytical method documents for testing biologics, including potency, impurities, content, and identity attributes (e.g., recombinant proteins, antibodies, ADCs, fusion proteins, enzymes).
• Author test methods related to various assays, including cell-based assays, residual Protein A, host cell proteins, residual DNA, and protein determination.
• Develop and write method validation protocols and reports in compliance with regulatory standards to support technology transfers and scale-up processes.
• Ensure that all documentation complies with FDA, EMA, ICH, and other applicable regulatory guidelines.
• Utilize electronic laboratory notebooks (ELNs) and electronic data storage systems to accurately document all scientific work.
• Ensure data integrity and proper management of experimental records in compliance with industry standards.

Qualifications & Skills:

• Bachelor's or Master’s degree in a relevant scientific discipline (e.g., Biochemistry, Biotechnology, Biology, Chemistry).
• Proven experience as a scientific or technical writer in the pharmaceutical/biotechnology industry, with a focus on analytical methods and method validation.
• Experience in authoring analytical methods, method validation protocols, and reports for biologics.
• Experience with electronic laboratory notebooks (ELNs) and electronic data storage systems.
• Familiarity with LIMS and Empower software platforms.
• Experience with regulatory submissions (e.g., IND, BLA) and knowledge of FDA, EMA, and ICH guidelines for biologics.
• Familiarity with Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).

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