Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Summary:
Lonza in Portsmouth, NH is looking for an MSAT Process Technical Writer. responsibility is to consistently deliver accurate and high-quality process Batch Records to Manufacturing in a timely manner for a number of different customer projects. The Lead role supports various customer campaigns to deliver accurate and high-quality records in a timely manner with an acquired first-rate skillset of editing, reviewing, and creating batch records and related documents. While communicating directly and indirectly with customers, departments, and within their own team, the Lead Technical Writer has advanced industry experience, knowledge, and ability to make decisions based on that experience. This position is able to manage multiple project schedules and is actively engaged in process improvements and development of junior team members while creating a positive work environment where interdepartmental collaboration, coaching, and performance feedback are commonplace
Key responsibilities:
40% - 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. Effectively work with all Lonza departments to provide technical support, expertise and leadership in overseeing the TWG systems. 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.
40% - Uphold a leadership role: Mentor/coach/train all technical writers while also providing peer reviews. Provide support when needed by the Supervisor or Manager, standing in as needed, as well as leading the rest of the team. Oversee day-to-day activities in TWG, including assignment of work, to ensure compliant, timely completion of tasks including support the issuing of batch records, editing and peer reviews as required. Provide supervision/guidance and coaching/development to personnel; participate in MAP-related activities.
10% - Perform daily work to support TWG functions, including interacting with internal and external stakeholders/customers, hosting/attending ad hoc meetings and interceding on behalf of TWG to resolve obstacles. Support other tasks as required, including Regulatory and Customer Audits, and participation in required reoccurring meetings.
10% - Oversee day-to-day activities in TWG, including assignment of work, to ensure compliant, timely completion of tasks including support the issuing of batch records, editing and peer reviews as required.
Key requirements:
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. Practical experience with Microsoft suite a plus. Ability to manage multiple priorities
Technical writing in the biotech industry preferred
Project management skills required
Strong MS Word experience required
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.