PRINCIPAL SCIENTIST

Fresenius Kabi USA•Wilson, NC

2d•$90,816 - $126,991

About The Position

The Principal Scientist coordinates and leads the introduction of non-routine and complex analytical methodologies, particularly non-chromatographic techniques, into the Quality Control laboratory. The role requires broad, strong knowledge of analytical chemistry, pharmaceutical development, and regulatory requirements. The Principal Scientist develops methods, assists with instrument qualifications, and performs method transfers, method verifications, and co-validations of compendial and non-compendial methods used in the QC laboratory. The position evaluates and introduces techniques to improve laboratory efficiency and serves as a recognized subject matter expert in key analytical areas, including across NAM and Global organizations. The Principal Scientist works with Plant Operations to resolve complex analytical and manufacturing issues related to process chemistry, and collaborates with Product Development, Technical Transfer, and Manufacturing Operations. The position participates in external organizations such as PDA and USP subcommittees and publishes articles on relevant analytical topics. It reports directly to QC management and may coordinate projects and provide leadership to scientists at grade level 15 and below. The salary range is $90,816–$126,991. The position is eligible for a bonus plan with a target of 6% of base salary. Final pay depends on factors including experience, education, knowledge, skills, and abilities. Benefits include a 401(k) plan with company contributions, paid vacation, holidays and personal days, an employee assistance program, medical and prescription drug coverage, dental and vision coverage, life insurance, disability coverage, and a wellness program. Employment is at-will and does not guarantee a permanent employment arrangement.

Requirements

Broad and strong knowledge of analytical chemistry, pharmaceutical development, and regulatory requirements.
Ability to develop analytical methods and assist with instrument qualifications.
Ability to perform and coordinate method transfers, method verifications, and co-validations.
Ability to lead complex projects with general guidance and keep assignments on schedule.
Ability to provide technical support for complex analytical and manufacturing issues.
Ability to lead projects and monitor the performance of assigned scientists.

Nice To Haves

Participation in external organizations such as ACS, PDA, or USP.
Experience publishing articles in pharmaceutical or technical journals on analytical topics.

Responsibilities

Identify and evaluate analytical technologies that can improve QC laboratory efficiency and capabilities, and lead their acquisition and implementation.
Serve as a QC knowledge leader on conformance of release and stability profiles with I&D development reports and regulatory submissions.
Publish articles in pharmaceutical or technical journals on relevant analytical chemistry topics.
Coordinate and execute method transfers, method verifications, and co-validations of testing procedures used in the QC laboratory.
Coordinate and execute verification protocols for vendor and USP analytical methods.
Evaluate methods in USP/PF and coordinate with USP to address potential issues.
Submit new methods to USP as needed.
Review results and verification reports following method transfers and execution of verification protocols.
Liaise between I&D departments or Production Units and the QC Chemistry laboratory to transfer and implement new testing procedures.
Participate in external organizations such as ACS, PDA, and USP.
Serve as the subject matter expert for critical tests supporting new product launches.
Identify and investigate complex QC laboratory problems and provide technical support to resolve them.
Prepare documentation for regulatory submissions as required.
Review, update, and approve documentation, including protocols, test methods, SOPs, and raw material and finished product specifications.
Participate in orientation and training of laboratory employees in new analytical method techniques.
Handle complex projects with general guidance, establish work priorities within assigned authority, and keep assignments on schedule.
Function as analytical project leader in interdepartmental meetings.
Provide project leadership to assigned scientists at grade level 15 and below, monitor their performance, and provide performance input to laboratory management.
Interface with Plant Operations and Technical Transfer personnel to support and resolve plant technical issues requiring analytical expertise.