Principal Scientist

Germer International - Pharmaceutical Recruiting; Waterloo (IA); On-site; USD 120,000 - 180,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking a Principal Scientist for a pharmaceutical client in Waterloo, IA. The role focuses on evaluating and interpreting analytical results and developing, validating, and transferring analytical methods for APIs, intermediates, and raw materials.

This highly technical position requires advanced chemistry degrees and extensive experience with GMP and DEA regulations, plus proficiency with instruments such as HPLC, GC, GC/MS, and FTIR.

Qualifications

• Ph.D. in Chemistry or related field with minimum 6 years of experience in a lab environment, pharmaceutical experience preferred.
• M.S. in Chemistry or related field with minimum 10 years of experience in a lab environment, pharmaceutical experience preferred.
• B.S. degree in Chemistry or related field with 14 years of experience in a lab environment, pharmaceutical experience preferred.

Responsibilities

• Develop, validate, and transfer analytical methods for APIs, intermediates, and raw materials.
• Safely develop, establish, and validate testing methodologies for materials and products.
• Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, and particle size analyzer.
• Write technical reports documenting analytical methods and maintain laboratory notebooks.
• Ensure GMP SOPs and DEA regulations compliance; transfer methods to QC and Process Support.
• Coordinate off-site testing and support investigations within Analytical Development and Quality Control.

Skills

Analytical Method Dev

Analytical Problem Solving

Team Collaboration

Education

Ph.D. in Chemistry

M.S. in Chemistry

B.S. in Chemistry

Tools

HPLC

GC

GC/MS

FTIR

Titrator

Particle Size Analyzer

Job description

Our pharmaceutical client is seeking a Principal Scientist who will be responsible for evaluating and interpreting analytical results, as well as developing, validating, and transferring analytical methods for APIs, intermediates, and raw materials. If you are someone who wants to be apart of a highly technical environment with a lot of growth, this role may be the one for you!

Responsibilities:

• Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
• Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
• Perform analytical chemistry assays based on new and existing methodologies
• Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
• Write technical reports to document analytical methods
• Maintain laboratory notebooks documenting work
• Maintain compliance with GMP SOPs and DEA regulations
• Transfer documented analytical methods to the QC and Process Support Group departments
• Set up new or existing analytical methods for compound identification, purity and potency testing.
• Coordinate off-site testing as necessary
• Conduct testing of analytical samples for the Chemical Development Department as needed.
• Qualify reference materials.
• May also perform other duties as required.

Qualifications:

• Ph.D. in Chemistry or related field with minimum 6 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 14 years of experience in lab environment, pharmaceutical experience preferred.