Technical Writer

Join a dynamic Manufacturing Sciences team supporting the production of life-changing biologics and antibody-based products. As a Technical Writer I, you will play a critical role in investigating manufacturing events, analyzing production data, and authoring high-quality investigation reports that directly support GMP manufacturing operations.

This position is ideal for a scientifically minded professional with a background in biology, biotechnology, biochemistry, or a related field who enjoys problem-solving, technical writing, data analysis, and cross-functional collaboration. You'll work closely with Manufacturing, Quality, and Process Sciences teams to identify root causes, drive corrective actions, and support continuous improvement initiatives in a highly regulated environment.

• Review manufacturing batch records, production documentation, and quality records for accuracy, completeness, and compliance.

• Investigate manufacturing events and deviations by gathering data, conducting analysis, and collaborating with cross-functional stakeholders.

• Author clear, concise, and technically accurate investigation reports that support quality and manufacturing operations.

• Perform root cause analyses to identify process gaps, contributing factors, and opportunities for improvement.

• Analyze manufacturing and process data to identify trends, assess risk, and support decision-making.

• Collaborate with Manufacturing, Quality Assurance, and other functional teams to resolve quality-related issues.

• Support implementation of process improvements and continuous improvement initiatives.

• Interpret data and records related to biologics manufacturing, antibody production, cell culture, protein purification, and related processes.

• Manage multiple investigations and documentation activities while meeting quality standards and timelines.

• Present findings and recommendations through written reports and team discussions.

• Bachelor's degree in Biology, Biochemistry, Cell Biology, Molecular Biology, Biotechnology, or a related scientific discipline.

• Strong scientific foundation in cell biology, protein biology, or biologics manufacturing.

• Experience reviewing technical, manufacturing, laboratory, or quality documentation.

• Ability to analyze data, identify trends, and support investigative activities.

• Strong technical writing skills with the ability to create clear and compliant documentation.

• Excellent attention to detail and organizational skills.

• Proficiency with Microsoft Office, including Excel.

• Strong communication and collaboration skills.

• Ability to work independently while managing multiple priorities in a fast-paced environment.

• Experience in biologics, cell culture, protein therapeutics, antibody production, protein purification, immunoassays, or related scientific fields.

• Exposure to GMP-regulated manufacturing, quality systems, or pharmaceutical/biotechnology environments.

• Experience writing investigations, deviations, CAPAs, technical reports, or regulated documentation.

• Knowledge of antibody purification, conjugation processes, and immunoassay testing.

• Familiarity with Lean Manufacturing, Continuous Improvement, PPI, or similar methodologies.

• Experience working on cross-functional projects within manufacturing, quality, or process development organizations.

We're looking for someone who is:

• Analytical and naturally curious, with a passion for investigating and solving complex problems.

• Detail-oriented and committed to producing high-quality, accurate documentation.

• Comfortable interpreting scientific data and translating findings into clear written reports.

• Collaborative and effective when working across multiple…