Lead Scientist

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

Benefits offered by this job

Medical, dental and vision insurance

Life insurance

Disability insurance

401K with company match

Wellness program

Job summary

Fresenius Kabi is seeking a Lead Scientist in Quality Control Chemistry in the United States to oversee advanced analytical methods and ensure cGMP compliance across operations. The incumbent guides training, mentors analysts, and coordinates cross-site projects to meet departmental objectives.

The role requires expertise in instrumental analyses (HPLC, GC, TLC, AA, ICP-MS, KF) and the ability to author investigations for OOS/OOT and deviations, with strong leadership and communication skills.

Qualifications

• Advanced training in specialized analysis methods.
• Experience with OOS/OOT investigations.
• Proficiency with cGMP and regulatory guidelines.

Responsibilities

• Articulate work issues to management and peers.
• Performs high-level instrumental analyses (HPLC, GC, TLC, AA, ICP-MS, KF).
• Networks with FK sites and departments to coordinate projects and ensure compliance.
• Author/direct investigations for OOS, OOT, and deviations.
• Lead training modules and mentor analysts.
• Summarize findings from evaluations and investigations clearly.
• Peer review of data and documentation for accuracy.

Skills

Analytical chemistry

Leadership

Trainer/mentoring

cGMP knowledge

Tools

HPLC

GC

TLC

AA

ICP-MS

KF

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

• 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, and wellness 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.