Principal Scientist

Germer International - Pharmaceutical Recruiting; Waterloo (IA); On-site; USD 120,000 - 170,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking a Principal Scientist to lead analytical method development, validation, and transfer for APIs, intermediates, and raw materials. The role focuses on evaluating results and ensuring compliance in a highly technical environment.

The candidate will develop testing methodologies, interpret data, and document methods while coordinating with QA and Production.

Qualifications

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

Responsibilities

• Develop, establish, and validate analytical testing methodologies for raw materials, intermediates, and final products.
• Investigate and resolve analytical technical issues within Analytical Development and Quality Control teams.
• Perform analytical chemistry assays based on new and existing methodologies.
• Operate analytical instruments such as HPLC, GC, GC/MS, FTIR, and titration equipment.
• Write technical reports documenting analytical methods and maintain lab notebooks.
• Ensure compliance with GMP SOPs and relevant regulations (DEA).
• Transfer validated methods to QC and Process Support Group departments.
• Set up new or existing analytical methods for identity, purity, and potency testing.
• Coordinate off-site testing as needed and support Chemical Development.

Skills

Analytical chemistry

Method development

Data interpretation

Team collaboration

Education

Ph.D. in Chemistry or related field

M.S. in Chemistry or related field

B.S. in Chemistry or related field

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.