Senior Scientist Position Available In Lee, North Carolina

Job Description The Scientist will support the Quality Control Method Transfer and Validation team by performing method validation activities including drafting protocols and reports, executing validation assays, and conducting data analysis. This role also involves procedural updates, reviewing various reports, and ensuring compliance with cGMP and data integrity principles. Responsibilities Independently conceptualize, plan, and execute laboratory experiments. Collaborate with colleagues and subject matter experts to determine the most suitable analytical methodologies to support project initiatives, including the use of computational predictive tools, modeling software, and data visualization tools. Lead and manage multiple projects, assisting teams in developing effective strategies for analytical needs and controls. Engage with the method development team and participate in both in-process and final product sample analyses. Author relevant sections of technical reports to support interdepartmental technology and method validation and transfer processes. Prepare technical reports, critically review data, and evaluate new instrumentation and analytical techniques/approaches as required. Independently analyze experimental data and provide conclusive insights. Mentor junior scientists and offer technical guidance. Essential Skills GMP experience (5+ years ideal). Extensive hands-on experience in pharmaceutical method transfer, validation, and development of relevant assays. Strong experience in troubleshooting assays and improving methods. Proficiency in technical writing and presentation skills. Experience with bioburden, endotoxin, and molecular biology. Additional Skills & Qualifications Bachelor’s degree with 10 years of industry experience, preferably in GMP; Master’s degree with 8 years of industry experience, preferably in GMP; or PhD with 4 years of industry experience. Experience with assay development, method validation, method development, and method transfer. Knowledge of quality control and LIMS. Familiarity with Waters HPLC, Maurice, PA 800, and chemistry plate-based assays. Work Environment This role is within a large pharmaceutical manufacturing organization focused on vaccine and mAb intermediate manufacturing. The team consists of five members dedicated to the project. The position follows a 1st shift schedule from Monday to Friday, 8 AM to 5 PM, with occasional weekend work on a rotating basis. The organization prides itself on being at the forefront of innovation, offering opportunities to work on high-profile projects and train on various methods. The company maintains a flexible, innovative, and customer-oriented culture, contributing directly to the delivery of safe and effective products to patients.