New

LEAD SCIENTIST

Fresenius Kabi USA, LLC
life insurance, 401(k)
United States, North Carolina, Wilson
5200 Corporate Pkwy (Show on map)
Jan 30, 2025
Job Summary A Lead Scientist in Quality Control Microbiology has broad expertise in routine as well as complex microbiological methods execution and validation. The incumbent is typically assigned the more complex test methods due to their advanced training and/or extensive experience. Additionally, the Lead Science is responsible for assigned the Quality Control Supervisor/Manager in ensuring the laboratory successfully operates in compliance with cGMP expectations and other laboratory regulations. Oversees and organizes the training and development of less experienced analysists n the group. Responsible for reviews and approval of method validation testing results performed in the Microbiology Method Validations department. Writes and revises standard operating procedures (SOP). Develops and executes study protocols to validate production and laboratory methods. Supports Plant equipment qualifications and re-qualifications. Prepares summaries for Tech Transfer and Regulatory Submissions. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT * Be able to articulate work related issues clearly and effectively to management and peers * Networks with other FK sites and departments to help coordinate projects and ensure compliance when needed. * Independently authors and directs investigative studies, deviations, and other necessary documents for the Quality Control microbiology department. o Investigates nonconforming test results for product impact, root cause, and evaluates results to provide conclusions and appropriate corrective action. o Investigates deviations from SOP requirements as directed by supervision for potential impact to product and materials and derives root cause of the incident. o Able to summarize findings from evaluations, investigations, protocols, in a clear, concise manner. * Advanced working knowledge of KabiTrack and recording Investigations such as OOS, OOT, OOL and Events/Incidents. * Advanced working knowledge of Documentum for SOP authorship, protocol development and training modules o Generates and updates SOPs for microbiology test procedures as needed o Develops and execute investigative studies & protocols for validations and/or special projects o Update and improve training modules for QC Microbiology methods. * Displays expertise in documentation requirements of the department as well as cGMP, GDP/GLP practices. * Trains analysts on newly implemented laboratory techniques as a Qualified Trainer and/or mentor. * Provides technical expertise and leadership where necessary. Makes recommendations for future courses of action using independent judgement and reasoning. * Performs peer review of data to ensure compliance and accuracy and conformance to specifications * Performs technical review of documentation, procedures, reports, etc. * Ready and able to learn comprehensively about a new subject (i.e. new instrumentation, methodology, technique), and communicate it to less experienced personnel. * Develop and validate Microbiological test methods for SOP updates. Prepares summaries for Regulatory submissions. * Understands department priorities and importance of planning ahead for assigned projects. Works independently. * Supports all plant equipment re-qualification studies including maintenance and calibration not performed by metrology of the BIER Unit (Biological Indicator (BI) Lab activities, endotoxin test units). * Supports Tech Transfer for execution of stability/ validation batches and provides Protocol summaries of Microbiology testing to Tech Transfer. * Maintains knowledge of cGMPs and GLPs and compendia methods. * Ensures safety related polices are adhered and makes recommendations to enhance or improve safety policies. * Performs special testing and project work as directed by management. REQUIREMENTS * Possess a B.S. in Microbiology, or Biology. * Typically, 5-8 years of experience in the pharmaceutical industry, or a M.S degree with 3+ years' experience, or Ph.D. with 0-2 years' experience. * A working knowledge of pharmaceutical manufacturing and experience with cGMP rules, GLP/GDP, USP and ICH guidelines is required. * Excellent written and oral skills. Planning and organization skills necessary for primary responsibilities. Must be proficient in Microsoft Office (Word, Excel, PowerPoint). Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.