Analytical Development, Principal Scientist I

Germer International; Charles City (IA); On-site; USD 90,000 - 120,000; Full time

Job summary

A reputable pharmaceutical company in Iowa seeks a Principal Scientist I to provide technical support across project teams. The role demands a Ph.D. in Chemistry (or related) with at least 6 years of experience or the equivalent with an M.S. or B.S. The candidate will develop and validate analytical methods while ensuring compliance with cGMP guidelines. Responsibilities include operating analytical instruments and collaborating across departments for analytical developments.

Qualifications

• Ph.D. with minimum 6 years or M.S. with minimum 10 years or B.S. with 14 years in lab environment.
• Pharmaceutical experience preferred.

Responsibilities

• Develop, establish, and validate analytical testing methodologies.
• Solve analytical technical issues within multiple departments.
• Perform analytical chemistry assays based on methodologies.
• Operate analytical instrumentation for testing.
• Write technical reports and maintain laboratory notebooks.
• Ensure compliance with GMP SOPs and DEA regulations.
• Transfer methods to QC and Process Support Group.

Skills

Analytical testing methodologies

HPLC

GC

GC/MS

FTIR

Titrator

Particle Size Analyzer

Education

Ph.D. in Chemistry or related field

M.S. in Chemistry or related field

B.S. degree in Chemistry or related field

Job description

Overview

The Principal Scientist I will provide technical support for multiple project teams. This individual will evaluate and interpret analytical results, develop, validate and transfer analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks.

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.