Lead Analytical Scientist - QC Development & Transfer

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

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