Description

The Principal 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.

• 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.

• Analytical Chemistry Knowledge: Strong understanding of advances theories in Analytical Chemistry.
• Cross Discipline Knowledge: Higher level understanding of other cross-functional technical departments, including organic chemistry and engineering.
• GMP/Regulatory Knowledge: Strong understanding of the GMP landscape and fundamental understanding of the industrial regulatory landscape; Good understanding of site SOPS, regulatory
• CMC concerns and can answer client questions and help them develop their clinical package.
• Instrumentation: Advanced knowledge of HPLC, GC, MS, and ability to train and troubleshoot problems with equipment (and help others).
• Communication: Excellent oral and written communication, often leading technical calls with clients.
• Problem Solving: Demonstrated ability to perform root cause analysis and solve problems.
• Time Management: Very good organizational skills and time management. Able to work on several key items at once including two or more medium complexity projects at once.
• Leadership: Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up.
• Technical Documentation and Review: Strong ability to generate key technical documents with minimal RFT issues and to review documents for others. Basic ability to write new SOP.
• External Influence: Strong demonstrated ability to independently steer client or technical teams; ability to redirect and point out scope change; good ability to work with site leadership team and steer local initiatives.
• Industry Credibility and Rapport: Demonstrated reputation as a leader within the Cambrex Analytical Community. Good publication record, where possible, and strong contributions to the Cambrex portfolio.
• Operational Excellence: Demonstrate ability to participate and share leadership on local OE initiatives.
• Change Orientation: Demonstrated contribution of input and ideas for larger Cambrex system level changes.

Ph.D. in Chemistry or related field with minimum 8 years of experience or M.S. in Chemistry or related field with minimum 12 years of experience or B.S. degree in Chemistry or related field with 16 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.

PI282216834