Analytical Development, Senior Scientist III

Cambrex - Charles City; Charles City (IA); Vor Ort; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Cambrex - Charles City in Charles City, IA seeks a Senior Scientist III to support multiple project teams, evaluating analytical results and developing methods for APIs, intermediates, and raw materials.

You will transfer methods, validate testing procedures, and ensure strict cGMP compliance across the lab. Strong communication and teamwork are essential for success in this role.

Qualifikationen

• Ph.D. in Chemistry or related field with minimum 4 years of experience or M.S. in Chemistry or related field with minimum 8 years of experience or B.S. degree in Chemistry or related field with 12 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.

Aufgaben

• 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.

Kenntnisse

Analytical chemistry

Communication

Team collaboration

GMP compliance

DEA regulations

Ausbildung

PhD in Chemistry

MS in Chemistry

BS in Chemistry

Tools

HPLC

GC

GC/MS

FTIR

Titrator

Particle Size Analyzer

Jobbeschreibung

Overview

The Senior Scientist III 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 4 years of experience or M.S. in Chemistry or related field with minimum 8 years of experience or B.S. degree in Chemistry or related field with 12 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.

PI287646811