LEAD SCIENTIST

Fresenius Kabi USA; North Carolina; On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical, Dental, Vision coverage

Life Insurance

Disability Insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA in North Carolina seeks a Lead Scientist in Quality Control Chemistry to apply advanced analytical methods including HPLC and GC in a cGMP environment. The role focuses on complex test methods and guiding junior analysts while ensuring regulatory compliance.

The incumbent will train staff, author investigations (OOS/OOT), and provide technical leadership across the QC lab, with emphasis on documentation, audits, and continuous improvement of analytical techniques.

Qualifications

• Proven ability to articulate work issues clearly to management and peers.
• Performs high-level testing with instrumental methods (HPLC, GC, TLC, AA, ICP-MS, KF) for chromatographic objectives.
• Network with sites/departments to coordinate projects and ensure compliance.
• Authors/directs investigations for OOS/OOT and deviations.
• Advanced knowledge of KabiTrack and documenting investigations.

Responsibilities

• Articulate work issues clearly to management and peers.
• Perform high-level testing using instrumental analysis (HPLC, GC, TLC, AA, ICP-MS, KF).
• Coordinate with FK sites and departments to ensure compliance.
• Author/direct investigations for OOS/OOT, deviations and related docs.
• Lead training modules and mentor analysts in new techniques.
• Review data and documentation for accuracy and compliance.
• Learn new instrumentation/methodology and teach others.

Skills

Analytical methods

Communication

cGMP knowledge

Mentoring

KabiTrack

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

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, 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.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.