Sr. Scientist

Job Summary

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. The role involves leading 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 becomes 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 identifies trends in the data as it is being generated in support of product validation and stability studies. They provide 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.

Responsibilities

• Coordinates and executes method transfers/method verifications/co-validations of testing procedures utilized within the Quality Control laboratory.
• Covers 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 keeps 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.

Qualifications

The ideal candidate should have a broad and strong knowledge of analytical chemistry, pharmaceutical development, and regulatory requirements. They must be capable of handling complex projects with only general guidance and establish work priorities for assignments within their authority. The position requires a minimum of 5 years of relevant experience in analytical chemistry, pharmaceutical development, and quality control. A PhD in Analytical Chemistry or a related field is preferred.

Skills

Strong analytical skills, knowledge of regulatory requirements, ability to troubleshoot analytical methods and instrumentation, and experience in method transfer and verification are essential. Proficiency in Microsoft Office applications is required. Knowledge of statistical software and proficiency in data analysis is desirable.

Benefits

Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.