Senior Analytical Chemist
Cedar Falls, IA 50613
Sr. Analytical Development Scientist
Our Client is a $300MM Pharmaceutical organization who has shown continuous success and improvement throughout their years of operation. Their serious commitment to high-quality standards has been proven through the products & services they provide via one of their manufacturing facilities, located in the Midwestern region of the US. They continue to strengthen that commitment through acquisitions and expansion projects across all of their domestic and international sites. Their mission is to continue to being aboard experienced professionals within the Pharmaceutical industry to oversee core elements of their operation. They are currently seeking Sr. Analytical Development Scientists who will provide technical support and leadership to multiple project teams. The Senior Analytical Chemist 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.
- With minimal supervision, safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products.
- 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 necessary.
- Qualify reference materials.
- Advanced Chemistry degree desired, with a PhD preferred
- Minimum BS degree in Chemistry or closely related field required, with 7+ years of experience in manufacturing support laboratory
- Experience with dissolution and chemosensory testing highly desired
- Familiarity with compliance requirements within cGMP, safety and regulatory environments
- Operational knowledge of analytical instrumentation like HPLC, GC, GC-MS, FTIR, UV-VIS equipment, and data stations required
- Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment
- The ability to solve extremely complex problems where analysis of situations or data requires an evaluation of intangible variables
- Ability to work in a highly independent and self-directed work environment.