Manufacturing Process Expert

Lonza • Walkersville, MD

2d • $103,000 - $175,000 • Remote

About The Position

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.

Requirements

• 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
• Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives

Responsibilities

• 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

Benefits

• 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)

What This Job Offers

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