Analytical Development, Sr. Scientist III

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

Qualifications/Skills

• Analytical Chemistry Knowledge: Strong understanding of the fundamentals of Analytical Chemistry
• Cross Discipline Knowledge: Good understanding of the principles of cross-functional departments, including organic chemistry and engineering
• GMP/Regulatory Knowledge: Demonstrated understanding of industrial GMP and practical application to Cambrex programs; Ability to help identify risks for regulatory compliance of violation of site SOP
• Instrumentation: Demonstrated ability to use, train, investigate root cause issues with HPLC, GC, good understanding of MS
• Communication: Good written and oral communication skills, ability to communicate with clients without manager supervision
• Problem Solving: Strong demonstration of problem solving, ability to lead investigations
• Time Management: Able to maintain timeline of key activities and use time efficiently; ability to handle projects without supervision though requires regular check in with manager
• Leadership: Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up
• Technical Documentation and Review: Ability to author and review key technical documents with minimal RFT errors. Can write new SOP with manager assistance
• External Influence: Ability to lead local project teams and steer clients to desired outcomes; ability to work with management to develop key local laboratory-based initiatives
• Industry Credibility and Rapport: Recognized scientific leader within the Cambrex organization, locally and possibly beginning to extend to other sites
• Operational Excellence: Actively participates in key operational excellence initiatives
• Change Orientation: Active participation and support for implementation of Cambrex system level changes/initiatives

Qualifications

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