DetailsDesign and conduct highly complex experiments using the following instrumentation: high-performance liquid chromatography (HPLC) and gas chromatography (GC) with emphasis on mass spectrometry (MS) in support of product method development and validation of consumer health products; Plan, purchase, and maintain the usage of analytical instrumentation; plan and ensure proper execution of analytical experiments of the highest complexity to provide sound analytical methods; provide expertise in structural elucidation of unknowns and degradations products; act as a team member /coach with cross functional project responsibilities on assigned projects; undertake line management and staff development responsibilities for assigned staff; provide expertise in the areas of analytical science and technology; method development and validation, structure elucidation of impurities, state-of-the-art methodology and installation and qualification of equipment within AS&T site or third party laboratories; author laboratory investigations, deviations, corrective/preventive actions, change requests, monographs, SOPs, and scientific protocols and reports; conduct operation and qualification of analytical laboratories and equipment at site level with expert knowledge and state-of-the-art processes and systems; execute the Over-the Counter (OTC) Quality Control network and lead activities related to analytical methods and instrumentation, as well as troubleshooting and resolving investigations to facilitate solutions to complex challenges; perform and lead technical functions, such as unknown impurity identification, method development, method validation, and method transfers for large and small molecule pharmaceuticals; support sites, Third Party Organizations and R&D in the preparation, management and follow up of Health Authority inspections with regard to analytical methodology, equipment and systems; local plant support activities including investigation support and analytical method remediation; utilize proactive thinking to generate creative solutions to complex technical problems; proactively monitor and communicate emerging regulations in area of expertise and assess the relevance for OTC; drive the implementation across OTC, where necessary; provide technical leadership on projects of the highest analytical complexity; oversee the analytical development strategy on assigned projects.

Basic QualificationsMaster's in Pharmaceutical Science or related field, or foreign equivalent, plus five (5) years of operational experience in a manufacturing site. Must have five (5) years of experience with: Developing and testing consumer health products using advanced analytical chemistry to implement laboratory methodology, quality systems and equipment; High-performance liquid chromatography (HPLC) developing analytical testing methods in a regulated (GMP) environment; Gas chromatography (GC) developing analytical testing methods in a regulated (GMP)environment; Waters Empower data acquisition software; Mass spectral detectors for GC; and Mass spectral detectors for HPLC.

Preferred Qualifications: None

Justification

Location

Primary Address: 10401 Highway 6, Lincoln, NE 68517

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