Cambrex High Point Senior Analytical Chemist in Charles City, Iowa
GENEROUS RELOCATION ASSISTANCE!!
#1 small molecule API Contract Manufacturing Organization (CMO) in the USA
Double digit sales growth each of the last 5 years
Recent $75 million expansion of our large-scale API facility
Winner of 30 CMO Leadership Awards in 2017
IOWA – Ranked #1 state for best place to live by US News and World Report
Leading Western supplier of generic APIs including ADHD and other controlled substances
TheSenior Analytical Chemistwill 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, 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.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. (https://careers-cambrex.icims.com/jobs/1644/senior-analytical-chemist/job?mode=apply&apply=yes&in_iframe=1&hashed=-336240429)
Job LocationUS-IA-Charles City