Lead Scientist

Fresenius Kabi USA • Wilson, NC

1d • Onsite

About The Position

A Lead Scientist in Quality Control Chemistry possesses extensive knowledge in both routine and complex chemical analysis methods. This role typically involves handling more intricate test methods due to advanced training in specialized analytical techniques. Additionally, the Lead Scientist supports the Quality Control Supervisor in ensuring the laboratory operates in compliance with cGMP and other relevant regulations. A key aspect of the role is overseeing and organizing the training and development of less experienced analysts within the team. Fresenius Kabi is a global healthcare company specializing in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition, providing essential support for critical and chronically ill patients.

Requirements

• Broad expertise in routine as well as complex chemical methods of analysis
• Advanced training in specialized methods of analysis
• Advanced working knowledge of KabiTrack
• Expertise in documentation requirements of the department as well as cGMP, GDP/GLP practices

Responsibilities

• Be able to articulate work related issues clearly and effectively to management and peers
• Performs and demonstrates expertise in high level testing utilizing instrumental methods of analysis (HPLC, GC, TLC, AA, ICP-MS, KF) with emphasis on chromatography to meet departmental objectives.
• Networks with other FK sites and departments to help coordinate projects and ensure compliance when needed.
• Independently authors and directs investigative studies (required for OOS or OOT results), deviations, and other necessary documents for the Quality Control department.
• Advanced working knowledge of KabiTrack and recording Investigations such as OOS, OOT, and Deviations.
• Displays expertise in documentation requirements of the department as well as cGMP, GDP/GLP practices.
• Updates and improves training modules for new analytical techniques used within the Quality Control laboratory.
• 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.
• Able to summarize findings from evaluations, investigations, protocols, in a clear, concise manner.
• Performs peer review of data to ensure compliance and accuracy.
• 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.

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed