LEAD SCIENTIST

Fresenius Kabi USA; Wilson (NC); On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA is seeking a Lead Scientist in Quality Control Chemistry to lead routine and complex analytical methods. The role focuses on ensuring compliance with cGMP and related lab regulations while supervising training of junior analysts.

The incumbent oversees method development, data review, and investigative documentation for OOS/OOT events and deviations, using advanced instrumental analyses and KabiTrack systems. Strong mentoring and leadership are expected.

Qualifications

• Advanced training in specialized methods of analysis.
• Ability to prepare and review investigations for OOS/OOT.
• Strong knowledge of cGMP and GDP/GLP practices.
• Experience training and mentoring analysts.

Responsibilities

• Articulate work-related issues clearly to management and peers.
• Performs high-level testing using instrumental methods (HPLC, GC, TLC, AA, ICP-MS, KF).
• Coordinate projects and ensure regulatory compliance across sites when needed.
• Independently author and direct investigations for OOS/OOT and deviations.
• Lead training and mentoring of analysts as a Qualified Trainer.
• Summarize findings from evaluations and investigations clearly.
• Peer review of data to ensure accuracy and compliance.
• Technical review of documentation, procedures and reports.

Skills

HPLC

GC

TLC

AA

ICP-MS

KF

Regulatory compliance

Documentation & data review

Process training & mentoring

Tools

KabiTrack

Job description

Job Summary

A Lead Scientist in Quality Control Chemistry has broad expertise in routine as well as complex chemical methods of analysis. The incumbent is typically assigned the more complex test methods due to his or her advanced training in specialized methods of analysis. In addition, the Lead Scientist is responsible for assisting the Quality Control Supervisor in ensuring the laboratory successfully operates in compliance with cGMP and other laboratory regulations. Oversees and organizes the training and development of less experienced analysts in the group.

Salary Range $60,966 -$85,694

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• 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.

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.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.