Scientist II, Quality Control Analytical

About the role

Today, Lonza is a global leader in life sciences operating across three 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. Lonza is seeking an experienced Scientist ll, Quality Control Analytical to join their team in Portsmouth, NH. POSITION: Scientist II, Quality Control Analytical JOB LOCATION : 101 International Drive, Portsmouth, NH 03801 DUTIES: Manage, lead and execute analytical method transfer programs from initiation to completion, ensuring on time execution and adherence to program requirements and manufacturing readiness timelines. Develop, implement and lead the transfer of analytical methods, including method verification, qualification and validation activities aligned with program requirements business objectives. Identify potential challenges and risks associated with method transfers activities, developing mitigation strategies to ensure successful and on-time completion. Participate in cross-functional teams as a Quality Control subject matter expert and technical resource responsible for providing quality control oversight and support to Validation and Tech Transfer manufacturing operations internally or at contracted suppliers. Execute analytical testing as required to support on-time product release and in adherence with cGMP and the company's procedures, policies and principles. Review testing and laboratory records for accuracy and compliance with cGMP and the company's procedures policies and principles. Author, review, and/or approve SOPs, method transfer and validation plans, protocols, reports, specifications, and justification of specifications. Oversee analytical and QC activities for site and Contract Testing Laboratories. Identify, alert, and propose solutions to issues on instruments and test executions. Perform data review and trend analysis to support all areas of laboratory operation. Identify, facilitate, and/or lead continuous improvement efforts. Perform and lead investigations for out of specification and out of trending data as per cGMP standards. Support on-the-job training for junior QC personnel, review and escalate to management as needed. Manage and Maintain an adequate inventory of supplies needed for all analytical testing requirements including but not limited to pipets, containers, and consumables. MINIMUM REQUIREMENTS: Requires a Bachelor's degree, or foreign equivalent degree in Chemistry, Biochemistry, Biotechnology, or Molecular Biology and 10 years of progressive, post-baccalaureate experience in the job offered or 10 years of progressive, post-baccalaureate experience in a related occupation implementing equipment and test methods associated with the Spectrophotometry, Appearance testing and chromatographic methods; working in a cGMP laboratory; supporting projects and cross-functional teams within stated objectives and timelines; implementing regulatory requirements (e.g., US, EU, USP) and industry best practices and supporting regulatory fillings; and participating in method transfers. 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.