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.
The Stability Manager will supervise the daily activities of the QC Stability team with responsibility for implementing and maintaining cGMP Stability for all phases of development, clinical, and commercial drug products. Primary responsibility will include managing stability studies for client projects and stability data analysis. May oversee additional areas of responsibility within the Quality Control Lab such as Lab Support, Data Review, Raw Materials, or Product Analysis, as required.
Key responsibilities:
Manage and coordinate Lonza Tampa stability study program on development, clinical, and commercial drug products, summarize stability results to ensure scientific and technical execution.
Manage stability database, and perform data trending, forecasting, and reporting of metrics.
Creation, revision, and approval of SOPs, stability protocols, and reports in accordance with current GMP, FDA, EU, Global, and ICH guidelines and regulations.
Facilitates and executes stability study protocols strategy and design including calculation and execution of stability study set downs and pulls independently and through direct collaboration with cross-functional teams and clients.
Ensure Quality Control test methods, lab equipment maintenance/repair, calibrations, and record keeping are done in accordance with established procedures.
Record test results, disposition of raw materials, intermediate and finished goods.
Support validation of new/revised test methods and/or equipment, investigation of nonconformances, and new product launch activities.
Support the development of data for Quality Control specifications for new products, optimizing existing specifications and test methods.
Manages QMS records for QC Stability which includes deviations, change controls, CAPA, and other applicable stability-related investigations and events.
Ensure that the GMP stability program continuously aligns with FDA, ICH, and other international agencies.
Provide support, leadership, and training for members of the QC Chemistry department when necessary.
Managing laboratory projects as required.
Actively participates in customer and regulatory audits.
Provide strong teamwork in establishing a quality culture and shared accountability.
Perform other responsibilities to support the business as requested.
Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear.
Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible.
Stop work where deemed necessary to maintain safety.
Key requirements:
Minimum of bachelor’s degree required with preference for Chemistry or Chemical Engineering, Biochemistry or Biology.
Minimum of 5 years of experience in a GMP pharma environment.
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 a disability, protected veteran status, or any other characteristic protected by law.
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