Principal Scientist

Fresenius Kabi•Wilson, NC

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 analytical methods used in the QC laboratory. The position evaluates and introduces techniques to improve laboratory efficiency and serves as a subject matter expert in key analytical areas, including for organizations beyond MP, such as NAM and Global. The Principal Scientist works with Plant Operations and Technical Transfer to resolve complex analytical and manufacturing issues related to process chemistry, and collaborates with Product Development, Technical Transfer, and Manufacturing Operations. The role participates in external organizations and publishes articles on relevant analytical topics. It reports directly to QC management and may coordinate projects and provide leadership to scientists at grade levels 15 and below. The stated 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, prescription drug, dental and vision coverage, life insurance, disability coverage, and a wellness program. Employment is at-will.

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 method transfers, method verifications, and co-validations of compendial and non-compendial analytical methods.
Ability to handle complex projects with general guidance and establish priorities while keeping assignments on schedule.

Responsibilities

Identify and evaluate analytical technologies that may 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 documented in 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 QC testing procedures.
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 verification protocols.
Act as a liaison between I&D departments or Production Units and the QC Chemistry laboratory for transfer and implementation of testing procedures.
Participate in external organizations such as ACS, PDA, and USP.
Serve as a 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 orienting and training laboratory employees in new analytical techniques.
Handle complex projects with general guidance, establish work priorities within assigned authority, and keep assignments on schedule.
Lead analytical projects in interdepartmental meetings.
Provide project leadership to assigned scientists at grade levels 15 and below, monitor their performance, and provide input to laboratory management for performance reviews, recognition, and disciplinary processes.
Work with Plant Operations and Technical Transfer personnel to support and resolve plant technical issues requiring analytical expertise.