Sr. Scientist

Fresenius Kabi • Wilson, NC

1d

About The Position

The Senior Scientist is responsible for the coordination and leadership of method transfer/method verification/co-validation of compendial and non-compendial analytical methods utilized across Fresenius Kabi. Leads planning and coordination of method transfer/method verification activities in the transfer of analytical methods from the Innovation & Development (I&D) department or between Fresenius Kabi facilities to the Quality Control laboratory. Additionally, the Senior Scientist will become the expert within the Quality Control organization for the critical tests associated with new product launches and knowledge leader on the conformance of the release and stability profile as documented in development reports and the regulatory submission. The Senior Scientist can identify trends in the data as it is being generated in support of product validation and stability studies. Provides technical support to all testing laboratories within Fresenius Kabi as well as leadership and technical expertise in projects where troubleshooting of analytical methods and instrumentation is required. The position also requires a broad and strong knowledge of analytical chemistry, pharmaceutical development, and regulatory requirements. The Senior Scientist reports directly to QC management and may provide project supervision to scientists at grade levels 15 and below. The Senior Scientist works closely with Product Development, Technical Transfer and Manufacturing Operations personnel.

Requirements

• Broad and strong knowledge of analytical chemistry, pharmaceutical development, and regulatory requirements.

Responsibilities

• Coordinates and executes method transfers/method verifications/co-validations of testing procedures utilized within the Quality Control laboratory.
• Coordinates and executes the verification protocols to verify the vendor and USP analytical methods.
• Reviews the obtained results and verification reports after the execution of method transfers and verification protocols.
• Acts as liaison between I&D departments or Production Units and the QC Chemistry laboratory for the transfer and implementation of new testing procedures.
• Subject matter expert for performance of critical tests in support of new product launches.
• Knowledge leader within QC on the conformance of the release and stability profile as documented in the I&D development reports and regulatory submission.
• Identifies and investigates complex problems occurring in the QC laboratories and provides technical support in solving the problems.
• Prepares documentation for Regulatory Submission, as required.
• Reviews/updates/approves documentation such as protocols, test methods, SOPs, raw material/finished product specification, etc.
• Participates in the orientation and training of lab employees in new analytical method techniques.
• Capable of handling complex projects with only general guidance.
• Establishes work priorities for assignments within his/her authority and keep assignment completion on schedule.
• Functions as the analytical project leader in inter-departmental meetings.
• Provides project leadership to assigned scientists (i.e. grade 15 and below) and monitors performance of these individuals.
• Provides input to laboratory management of their performance to support the performance review, recognition and disciplinary processes.
• Interfaces with Plant Operations and Technical Transfer personnel to support and resolve plant technical issues where analytical expertise is needed.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

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