MSAT - Process Lead Technical Writer

Lonza • Portsmouth, NH

2d • Onsite

About The Position

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.

Requirements

• Bachelor's Degree required
• 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

Nice To Haves

• Life Sciences area is preferred
• Working experience of pharma/biotech (or equivalent) preferred
• Working knowledge of GMP / Biotechnology manufacturing background referred
• Some experience in QA and/or Documentation creation preferred
• Technical writing in the biotech industry preferred

Responsibilities

• Authoring of Batch Records
• Coordination of the delivery of timelines for SOPs and other support documents for approval of batch record
• Participation 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

Benefits

• 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 This Job Offers

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