Description

The Senior Scientist I 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: Good understanding of the Principles of Analytical Chemistry,

good laboratory experience.

Cross Discipline Knowledge: Basic understanding of the principles of cross-functional departments,

including organic chemistry.

GMP/Regulatory Knowledge: Demonstrated understanding of GMP as it relates to current work;

with less manager input, can help advise clients on key regulatory strategies.

Instrumentation: Good fundamental understanding and the ability to use/investigate issues with

HPLC, GC.

Communication: Good written and oral communication skills, ability to handle client requests with

manager review.

Problem Solving: Able to solve problems in the workplace and helps to lead 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: Able to support key OE initiatives.

Change Orientation: Locally supports changes associated with larger Cambrex initiatives.

Ph.D. in Chemistry or related field or M.S. in Chemistry or related field with minimum 4 years of

experience or B.S. degree in Chemistry or related field with 8 years of experience in lab environment.

Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.

PI281941749