MSAT – Process Lead Technical Writer
Location: On-site, Portsmouth, NH.
The MSAT Process Lead Technical Writer is responsible for the development, revision, and delivery of high-quality manufacturing Batch Records and process documentation that support the production of life-changing therapies. The successful candidate will combine strong technical writing expertise with project management and cross-functional collaboration skills to ensure documentation is accurate, compliant, and delivered on schedule. This position plays a vital role in maintaining operational excellence, regulatory compliance, product quality, and ultimately patient safety.
What you will get:
Competitive salary and comprehensive benefits package.
Opportunities for career development and advancement.
Supportive and collaborative team environment.
Access to cutting-edge technology and tools.
Commitment to employee well-being and safety.
Inclusive workplace culture.
Recognition and reward for your contributions.
Access to our full list of global benefits: https://www.lonza.com/careers/benefits
What you will do:
Authoring of Batch Records, coordination of the delivery of timelines for SOPs and other support documents for approval of batch record, participate in Project Team Meetings to coordinate project schedules and alignment of groups in regards to the writing, review, and approval of process of batch records.
Ensure Batch Records are consistently generated and delivered to Manufacturing in a timely manner, to a high level of quality, and with a high level of inter-departmental collaboration that ensures the promotion of Right-First-Time operations on the manufacturing floor.
Adhere to established departmental practices and protocols and independently create new cGMP documents. Participates in editing documents and managing document comments. Maintains and reviews schedules.
Perform daily work to support technical writing functions, including interacting with internal and external stakeholders/customers, hosting/attending ad hoc meetings and interceding on behalf of the team to resolve obstacles.
Support other tasks as required, including Regulatory and Customer Audits, and participation in required reoccurring meetings.
Oversee day-to-day activities, including assignment of work, to ensure compliant, timely completion of tasks including support the issuing of batch records, editing and peer reviews as required.
What we are looking for:
Bachelor's Degree required, Life Sciences area is preferred.
Working experience of pharma/biotech (or equivalent) preferred.
5-10 years in a production environment.
Working knowledge of GMP / Biotechnology manufacturing background referred, some experience in QA and/or Documentation creation preferred. Ability to manage multiple priorities.
Technical writing in the biotech industry preferred.
Project management skills required.
Strong MS Word experience required.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life science