Job Description

Job Description:

We are seeking a skilled professional to provide non-laboratory support for QC analytical methods, focusing on method validation and transfer projects. Key responsibilities include authoring analytical method documentation for QC release and stability testing of biologics, and developing method validation protocols and reports to support technology transfers.

Key Responsibilities:

• Draft and review comprehensive method validation protocols and reports, ensuring compliance with ICH, FDA, and EMA regulatory standards.
• Author QC-related documentation for biologics, including recombinant proteins, antibodies, ADCs, fusion proteins, and enzymes.
• Focus on analytical methodologies for assessing potency, impurities, content, and identity attributes (e.g., cell-based assays, residual Protein A, host cell protein, residual DNA, protein determination).

Experience Requirements:

• Strong independent technical writing experience in Quality Control and Regulatory departments, with the ability to perform as the primary author.
• Extensive knowledge in data analysis, method validation, and test methods for internal teams and external partners.
• Hands-on experience in QC laboratories is highly preferred.

Key Skills:

• Expertise in laboratory compliance and documentation practices.
• Proficient in using electronic laboratory notebooks and data storage systems to maintain accurate records.
• Strong communication and interpersonal skills, thriving in a team environment.
• Familiarity with LIMS and Empower software platforms.

Ability to document and analyze assay trends to ensure compliance and operational efficiency improvements

Job Tags

Similar Jobs