Manufacturing Process Expert

Manufacturing Process Expert Location: This position is currently remote. A future transition to an on-site location on the U.S. East-Coast/Mid-West is anticipated as the project progresses, with an expected timeline beginning in 2027. This is a full-time role with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m. What you will get: The full-time base annual salary for this position is expected to range between $103,000 to $175,000. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge. What you will do: As a Manufacturing Process Expert, you will support the execution and continuous improvement of GMP manufacturing operations, serving as a subject matter expert for your area. You will ensure safe, compliant, and efficient production while supporting the introduction of new equipment and processes into routine manufacturing. Own day-to-day execution of GMP manufacturing operations, ensuring safety, quality, and on-time delivery Serve as area SME, driving right-first-time performance and data-driven problem solving Author, review, and maintain GMP documentation (SOPs, batch records, logbooks) Lead and support deviations, investigations, CAPAs, and change controls Support tech transfer, validation activities, and audit readiness Troubleshoot process and equipment issues in collaboration with Engineering and Maintenance Train and coach operators on processes, GMP practices, safety, and data integrity Support CapEx activities as manufacturing user representative (URS input, FAT/SAT, commissioning, qualification) Drive continuous improvement using Lean tools to enhance efficiency, yield, and reliability What we are looking for: Experience in GMP manufacturing within a pharmaceutical, biotech, or CDMO environment Bachelor’s degree in Life Sciences or Engineering (e.g., Chemistry, Chemical Engineering, Pharmaceutical Sciences); advanced degree preferred Experience in small molecule and/or bioconjugation (conjugation) manufacturing Strong knowledge of GMP practices, including GDP and data integrity (ALCOA+) Experience with deviations, root cause analysis, CAPA, and change control systems Hands-on experience with manufacturing documentation and systems (MES, LIMS, ERP such as SAP) Familiarity with Lean principles and continuous improvement tools (Lean Six Sigma preferred) Understanding of EHS requirements and safe manufacturing practices Strong communication and collaboration skills with ability to train and influence teams Travel: Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives 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 sciences? Apply now.