Technical Writer 1

Job Title: Technical Writer 1Job Description

The Technical Writer 1 supports the Manufacturing Sciences team by investigating manufacturing events and preparing high-quality documentation related to biologics production. In this role, you review manufacturing records, analyze process data, collaborate closely with manufacturing and quality teams, and author investigation reports that directly support site operations. You apply strong scientific understanding of protein biology, cell biology, and antibody manufacturing processes to accurately assess manufacturing events, determine root causes, and clearly document findings. You work both independently and as part of a cross-functional team to address quality issues, drive process implementation, and contribute to continuous improvement initiatives across manufacturing operations.

Responsibilities

• Review manufacturing batch records and related documentation to ensure accuracy, completeness, and compliance with quality standards.
• Analyze manufacturing process data to understand production performance, identify trends, and support investigation activities.
• Independently author clear, technically accurate investigation reports that document manufacturing events, findings, and conclusions.
• Perform root cause analysis of manufacturing events, using scientific and process knowledge to identify underlying issues and contributing factors.
• Prepare compliant quality documentation that meets regulatory expectations, internal procedures, and submission timelines.
• Collaborate with manufacturing, quality, and other cross-functional teams to gather information, align on findings, and support resolution of quality issues.
• Support continuous improvement and Practical Process Improvement (PPI) or equivalent Lean initiatives to enhance manufacturing processes and workflows.
• Interpret production data and manufacturing records for biologics, protein therapeutics, antibody products, immunoassays, cell culture, and protein purification processes.
• Contribute to process implementation activities and cross-functional projects of varying complexity within the Manufacturing Sciences team.
• Apply understanding of antibody purification, conjugation processes, and immunoassay QC assays to investigate events and develop robust documentation.
• Manage multiple investigations and documentation tasks concurrently, ensuring timely completion and high-quality deliverables.
• Communicate findings, recommendations, and status updates clearly and professionally to stakeholders through written reports and verbal discussions.

Essential Skills

• Bachelor's degree in Biology, Cell Biology, Biochemistry, Molecular Biology, Biotechnology, or a closely related scientific discipline.
• Practical scientific knowledge in protein biology and cell biology, with the ability to understand manufacturing events and interpret production data.
• Experience reviewing and evaluating manufacturing batch records and related documentation for accuracy and completeness.
• Solid understanding of manufacturing processes and interdepartmental workflows, particularly within biologics or antibody production environments.
• Ability to independently write investigation reports and create compliant quality documentation that meets established standards and timelines.
• Demonstrated capability to identify root causes, analyze manufacturing records, and support investigative management activities.
• Proficiency in Microsoft Office applications, particularly Excel, for data analysis, documentation, and reporting.
• Excellent written and verbal communication skills, with strong attention to clarity, structure, and technical accuracy.
• High level of detail orientation, with strong accuracy and precision in documentation and data handling.
• Ability to thrive in a fast-paced, dynamic environment while managing multiple tasks and priorities.
• Strong project management and time management skills to handle investigations and cross-functional initiatives effectively.

Additional Skills & Qualifications

• Experience supporting biologics, protein therapeutics, antibody products, immunoassays, cell culture, protein purification, or process development.
• Understanding of antibody manufacturing workflows, including purification, conjugation processes, immunoassay testing, and GMP production environments.
• Familiarity with Practical Process Improvement (PPI) systems and tools, or equivalent Continuous Improvement or Lean methodologies.
• Experience collaborating with cross-functional teams on projects of varying complexity in a manufacturing or scientific setting.
• Exposure to medical writing, regulatory documentation, FDA-related requirements, or other regulated documentation environments.
• Results-driven and data-focused approach to work, with a strong analytical mindset.
• Positive, professional attitude and strong collaborative mindset when working with diverse teams.
• Ability to contribute to operational agendas and cross-functional projects that support site operations and quality improvements.

Work Environment

The role operates within a fast-paced, dynamic manufacturing sciences environment that supports biologics and antibody production. You work closely with manufacturing, quality, and other cross-functional teams to investigate events and improve processes across the production lifecycle. The work involves frequent use of Microsoft Office tools, particularly Excel, for data analysis and documentation. You engage with manufacturing operational flows such as antibody purification, conjugation processes, and immunoassay QC assays, and you interact with GMP-oriented production workflows and quality systems. The environment values collaboration, precision, and continuous improvement, offering opportunities to participate in Practical Process Improvement or other Lean initiatives while contributing directly to reliable, high-quality manufacturing operations.

Job Type & Location

This is a Contract position based out of Carlsbad, CA.

Pay and Benefits

The pay range for this position is $33.00 - $33.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Carlsbad,CA.

Application Deadline

This position is anticipated to close on Oct 22, 2026.