Analytical Development Senior Scientist II

Cambrex - Charles City; Charles City (IA); On-site; USD 85,000 - 120,000; Full time

Job summary

Cambrex - Charles City in Iowa is seeking a Senior Scientist II to provide technical support across project teams, develop and transfer analytical methods for APIs and raw materials, and ensure strict cGMP compliance.

Responsibilities include validating methods, operating HPLC, GC and FTIR, writing reports, maintaining notebooks, and transferring methods to QC and Process Support teams. Requires PhD/MS/BS in chemistry with relevant pharma experience.

Qualifications

• PhD with 2+ years or MS with 6+ years or BS with 10+ years in lab settings.
• Pharmaceutical experience is preferred and cGMP knowledge is essential.
• Excellent verbal and written communication and teamwork skills.

Responsibilities

• Develop, establish and validate analytical testing methods for materials and products.
• Actively participate in cross-functional teams to solve analytical issues.
• Perform analytical assays based on established and new methods.
• Operate HPLC, GC, FTIR, Titrator and Particle Size Analyzer.
• Write technical reports documenting methods and results.
• Maintain lab notebooks and ensure GMP SOP compliance.
• Transfer validated methods to QC and Process Support groups.
• Coordinate off-site testing when required.
• Conduct testing for chemicals developed by the department.

Skills

Analytical Chemistry

Team collaboration

Documentation

Clear communication

Education

PhD in Chemistry

MS in Chemistry

BS in Chemistry

Tools

HPLC

GC

FTIR

Titrator

Particle Size Analyzer

Job description

Overview

The Senior Scientist II 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, 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 2 years of experience or M.S. in Chemistry or related field with minimum 6 years of experience or B.S. degree in Chemistry or related field with 10 years of experience in lab environment, pharmaceutical experience preferred.

Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.

Equal employment opportunity, including veterans and individuals with disabilities.