Senior Method Development Scientist Position Available In Wake, 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, conducting data analysis, and updating procedures. This role requires meticulous review of various reports and data in accordance with cGMP and data integrity principles. The Scientist will play a key role in ensuring the effective transfer and validation of analytical methods within the organization. Responsibilities Independently conceptualize, plan, and execute laboratory experiments. Collaborate with colleagues and subject matter experts to determine suitable analytical methodologies for project initiatives, utilizing computational predictive tools, modeling software, and data visualization tools as necessary. 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 when necessary. Essential Skills Expertise in chemistry, method validation, and capillary electrophoresis. BS with 10 years of industry experience, preferably in GMP; MS with 8 years of industry experience, preferably in GMP; or PhD with 4 years of industry experience. GMP experience is essential, with 5+ years being ideal. Extensive hands-on experience and strong experience in pharmaceutical method transfer, validation, and development of relevant assays. Experience in troubleshooting assays and improving methods. Strong technical writing and presentation skills. Proficiency in molecular biology, HPLC, ELISA, CE-SDS, icIEF, and CE . Additional Skills & Qualifications Proficiency in assay development, method validation, method development, and method transfer. Familiarity with cGMP, quality control, LIMS, Waters HPLC, Maurice, capillary electrophoresis, 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 individuals dedicated to the project, working on a first shift schedule from Monday to Friday, with occasional weekend work required on a rotating basis. The standard work hours are from 8 AM to 5 PM. The work environment is innovative and customer-oriented, emphasizing quality and the delivery of safe and effective products to patients.