MSAT Process Technical Writer

Lonza • Portsmouth, NH

2d • Onsite

About The Position

Join Lonza’s Manufacturing Science & Technology (MSAT) team as a Process Technical Writer, where you will play a critical role in supporting the production of life-changing therapies. In this position, you will create, edit, and manage manufacturing batch records and cGMP documentation that directly support manufacturing operations, product quality, regulatory compliance, and patient safety.

Requirements

• Bachelor’s degree required; Biotechnology, Life Sciences, or a related discipline preferred.
• Experience in the pharmaceutical, biotechnology, or other regulated manufacturing industry preferred.
• Technical writing experience within a biotech, pharmaceutical, or cGMP environment preferred.
• Strong project management and organizational skills.
• Advanced proficiency with Microsoft Word and document management systems.
• Strong attention to detail and the ability to manage multiple priorities effectively.
• Effective communication and collaboration skills across cross-functional teams.

Responsibilities

• Create, edit, and format process batch records and cGMP documentation to ensure accuracy, clarity, and compliance.
• Manage document revisions, including scope reviews, approvals, justifications, and review coordination.
• Facilitate document review meetings and drive timely resolution of comments.
• Translate stakeholder feedback into compliant and effective documentation updates.
• Maintain documentation schedules that support manufacturing campaigns and production timelines.
• Communicate document status and escalate risks that could impact manufacturing readiness.
• Partner with internal subject matter experts to ensure documentation meets regulatory, customer, and business requirements.

Benefits

• Medical, dental and vision insurance.
• Opportunities to collaborate with Manufacturing, MSAT, Quality, and Operations teams.
• Professional development and career growth within a global life sciences organization.
• The opportunity to contribute to therapies that positively impact patients worldwide.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level