Analytical Development Scientist II

Job Overview

Responsibilities

Qualifications/Skills

Education, Experience & Licensing Requirements

About the Role

You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

About the Role

• Safely and effectively collect analytical data to help develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
• Perform analytical chemistry assays based on new and existing methodologies
• Operate analytical instrumentation such as HPLC, GC, GC/MS, LC/MS, FTIR, Titrator, Particle Size Analyzer
• 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
• Coverage off-site testing as necessary
• Conduct testing of analytical samples for the Chemical Development Department as needed
• Collect analytical data to help qualify reference materials
• May also perform other duties as required

About the Role

• Analytical Chemistry Knowledge: Basic understanding of the principles of Analytical Chemistry, some practical laboratory experience
• Cross Discipline Knowledge: Basic understanding of the principles of cross-functional departments, including organic chemistry
• GMP/Regulatory Knowledge: Basic understanding of GMP; with manager assistance can help to answer client inquiries related to SOP or regulatory guidance
• Instrumentation: Good fundamental understanding and ability to use/investigate issues with HPLC, GC
• Communication: Good written and oral communication skills, demonstration of successful interdepartmental communication
• Problem Solving: Ability to support laboratory investigations with manager support
• Time Management: Reasonable ability to handle one or more tasks or projects, often with supervision
• Leadership: Shares ideas with peers
• Technical Documentation and Review: Ability to write technical documents with assistance
• External Influence: Occasionally participates in internal project team meetings, as needed; demonstrated ability to work within a team matrix
• Industry Credibility and Rapport: Known as a solid scientific contributor within the department/group
• Operational Excellence: Demonstrated interest in improvements of operational aspects of the group/team
• Change Orientation: Provides constructive feedback for Cambrex initiatives