Position Title: Senior Analytical Chemist
Reports to: Group Leader, Analytical Development
Location: Charles City, IA
The Senior Analytical Chemist 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.
Accountabilities and Responsibilities:
- 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.
All employees are required to adhere to EPA, DEA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
- 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 Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the ‘Arthur I. Mendolia Scholarship Program.’ Relocation assistance will be offered for this position.