Lead Scientist (PFS)

Fresenius Kabi USA • Wilson, NC

1d • Onsite

About The Position

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. Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Their 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, their dedicated team is united by a 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. This purpose is called caring for life. The U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

Requirements

• Broad expertise in routine as well as complex chemical methods of analysis.
• Advanced training in specialized methods of analysis.
• Ability to assist the Quality Control Supervisor in ensuring the laboratory successfully operates in compliance with cGMP and other laboratory regulations.
• Ability to oversee and organize the training and development of less experienced analysts in the group.
• Expertise in high level testing utilizing instrumental methods of analysis (HPLC, GC, TLC, AA, ICP-MS, KF) with emphasis on chromatography.
• Advanced working knowledge of KabiTrack and recording Investigations such as OOS, OOT, and Deviations.
• 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

• Career Level: Senior
• Education Level: No Education Listed