PRINCIPAL SCIENTIST

Fresenius Kabi; North Carolina; On-site; USD 91,000 - 127,000; Full time

Benefits offered by this job

401(k) with company contributions

Medical, dental and vision coverage

Life insurance

Wellness program

Job summary

Fresenius Kabi in the United States seeks a Principal Scientist to lead introduction of non-routine analytical methodologies in the QC laboratory. You will develop methods, transfer and validate assays, and act as SME across NAM and Global with regulatory considerations.

You will collaborate with Product Development, Technical Transfer, and Manufacturing Operations, publish articles, and partner with external organizations while guiding junior scientists and coordinating cross-functional

Qualifications

• Broad knowledge of analytical chemistry and regulatory requirements.
• Experience in method development and instrument qualification.
• Coordinate transfers, verifications and co-validations of testing procedures.

Responsibilities

• Identify and evaluate new analytical technologies for QC labs.
• Lead method transfers, verifications and co-validations of testing procedures.
• Coordinate verification protocols with USP and vendor methods.
• Publish articles in pharmaceutical/technical journals on analytical topics.

Skills

Analytical chemistry

Leadership

Job description

Job Summary

The Principal Scientist is responsible for the coordination and leadership of the introduction of non-routine and/or complex analytical methodologies (i.e. non-chromatographic analytical techniques) to the Quality Control laboratory. The position requires a broad and strong knowledge of analytical chemistry, pharmaceutical development, and regulatory requirements. The Principal Scientist will perform method development and assist with instrument qualifications to introduce these new techniques. They will also perform method transfers/method verifications/co-validation of compendial and non-compendial analytical methods utilized in the QC lab. They will evaluate, develop and introduce new techniques to the QC lab to improve lab efficiency. They will be the recognized SME in key analytical areas of interest. They will also be recognized as SME’s outside of MP (i.e. NAM and Global). They will work with plant operations to resolve complex analytical and manufacturing issues with respect to the chemistry of the process. The Principal Scientist will join outside organizations such as PDA, USP subcommittees, etc. In addition, the Principal Scientist will publish articles in pharmaceutical/technical journals on relevant analytical topics. The Principal Scientist reports directly to QC management and may provide project coordination to scientists at grade levels 15 and below. The Principal Scientist works closely with Product Development, Technical Transfer and Manufacturing Operations personnel.

Salary Range: $90,816 - $126,991

Position is eligible to participate in a bonus plan with a target of 6% of the base salary

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. 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.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Identifies and evaluates new analytical technologies that can improve the operational efficiency and capabilities of the QC laboratories and leads the acquisition and implementation of the new technology
• Knowledge leader within QC on the conformance of the release and stability profile as documented in the I&D development reports and regulatory submission.
• Publishes articles in pharmaceutical/technical journals on relevant analytical chemistry topics.
• 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.
• Evaluates methods in USP/PF and coordinates with USP to address potential issues.
• Submits new methods to the USP as needed.
• 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.
• Actively participates in outside organizations such as ACS, PDA, USP.
• Subject matter expert for performance of critical tests in support of new product launches.
• 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.

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, andwellness 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.