Analytical Development Scientist II

Overview:

The Scientist II will provide analytical support for multiple project teams. This individual will collect and analyze data to support the development, validation and transfer of 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 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.
• Coordinate 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

Qualifications / Skills::

• 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

Qualifications:

• M.S. in Chemistry or related field with minimum 2 years of experience or B.S. degree in Chemistry or related field with 6 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.