Senior Analytical Chemist

Job DescriptionThe Senior Analytical Chemist will provide technical support and leadership to multiple project teams and 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.ResponsibilitiesWith minimal supervision, safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final vestigate 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 methodologiesOperate analytical instrumentation such as HPLC, GC, FTIR, Titrator, Particle Size AnalyzerWrite technical reports to document analytical methodsMaintain laboratory notebooks documenting workMaintain compliance with GMP SOPs and DEA regulationsTransfer documented analytical methods to the QC and Process Support Group departmentsSet up new or existing analytical methods for compound identification, purity, and potency testing.Coordinate off-site testing as necessaryConduct 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 related to the Company; and to adhere to all client''s 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.QualificationsAdvanced Chemistry degree desired, with a Ph.D. preferredMinimum BS degree in Chemistry or closely related field required, with 7+ years of experience in manufacturing support laboratoryExperience with dissolution and chemosensory testing is highly desiredFamiliarity with compliance requirements within cGMP, safety, and regulatory environmentsOperational knowledge of analytical instrumentation like HPLC, GC, GC-MS, FTIR, UV-VIS equipment, and data stations requiredDemonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environmentThe ability to solve extremely complex problems where analysis of situations or data requires an evaluation of intangible variablesAbility to work in a highly independent and self-directed work environment.BenefitsThe client 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.

Created: 2021-11-29