Bachelor’s degree in Biotechnology, Life Sciences, or related field preferred.
Experience in pharmaceutical, biotechnology, or regulated manufacturing industries preferred.
Technical writing experience in a biotech, pharmaceutical, or cGMP environment preferred.
Strong project management and organizational skills.
Advanced proficiency in Microsoft Word and document management systems.
Strong attention to detail with 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 for accuracy and compliance.
Manage document revisions, including reviews, approvals, and coordination.
Facilitate document review meetings and resolve comments promptly.
Translate stakeholder feedback into compliant documentation updates.
Maintain documentation schedules to support manufacturing timelines.
Communicate document status and escalate risks affecting manufacturing readiness.
Partner with subject matter experts to ensure documentation meets regulatory and business requirements.
Benefits
Agile career and dynamic working culture.
Inclusive and ethical workplace.
Compensation programs recognizing high performance.
Medical, dental, and vision insurance.
Opportunities for collaboration with various teams.
Professional development and career growth within a global organization.
Chance to contribute to therapies impacting patients worldwide.
Full Job Description
MSAT Process Technical WriterLocation: Portsmouth, NH, USAMonday-Friday, Onsite
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.
What you will get:
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
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 you will do:
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.
What we are looking for:
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.
About Lonza America Inc
Lonza America Inc is a subsidiary of Lonza Group, a Swiss multinational company that provides products and services to the pharmaceutical, biotech, and specialty ingredients markets. Lonza America Inc is responsible for the North American market and offers a range of products and services, including custom manufacturing, research and development, and quality control testing. The company has a strong focus on sustainability and has implemented various initiatives to reduce its environmental impact. Lonza America Inc was founded in 1897 and has since grown to become a leading provider of products and services in the pharmaceutical and biotech industries.
