Job Overview
The Senior 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.
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, 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.
Qualifications/Skills
Analytical Chemistry Knowledge: Strong understanding of the fundamentals of Analytical Chemistry, good laboratory experience.
Cross Discipline Knowledge: Good understanding of the principles of cross-functional departments, including organic chemistry and engineering.
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: 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 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: Good understanding of time management and can self-organize with or without supervision.
Leadership: Strong demonstration of sharing key ideas across the group.
Technical Documentation and Review: Ability to write technical documents with minimal RFT errors.
External Influence: Actively participates in regular internal project team meetings, including submission of key technical reports; organizes group level initiatives within the larger scientific team.
Industry Credibility and Rapport: Known as a solid scientific contributor within the site.
Operational Excellence: Able to support key OE initiatives.
Change Orientation: Locally supports changes associated with larger Cambrex initiatives.
Education, Experience & Licensing Requirements
Ph.D. in Chemistry or related field with minimum 2 years of experience or M.S. in Chemistry or related field with minimum 6 years of experience or B.S. degree in Chemistry or related field with 10 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.
