A Lead Scientist in Quality Control Microbiology has broad expertise in routine as well as complex microbiological methods execution. 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 assignments from 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 in the group. 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.Role Responsibilities:
- 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
- Advanced working knowledge of KabiTrack and recording Investigations such as OOS, OOT, OOL and Events/Incidents.
- Investigates nonconforming test results for product impact, root cause, and evaluates results to provide conclusions and appropriate corrective action.
- Investigates deviations from SOP requirements as directed by supervision for potential impact to product and materials and derives root cause of the incident.
- Able to summarize findings from investigations in a clear, concise manner.
- Develops and execute investigations or investigative studies
- Advanced working knowledge of Documentum for SOP authorship and training modules
- Independently authors necessary documents for the Quality Control microbiology department
- Generates and updates SOPs for microbiology test procedures as needed
- 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.
- Understands department priorities and importance of planning ahead for assigned projects. Works independently.
- Supports all plant equipment re-qualification studies
- Supports Product Development for execution of trial/stability/ validation batches
- 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.
- 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).
Company DescriptionFagron was founded in Rotterdam (The Netherlands) in 1990 and is a dynamic organization with over 2,600 employees worldwide. As the global market leader in personalized medicine, we are highly passionate about being at the forefront of our field. Each day, we are committed to improving the lives of millions of people across the world by optimizing and innovating personalized pharmaceutical solutions.