Senior Analytical Scientist

As a member of the Akorn Quality Analytical Services organization, the Senior Analytical Chemist will be responsible for providing direct analytical leadership to Akorn operations and Quality. The Senior Analytical Chemist will work within a dedicated QAS Laboratory. This is a laboratory position and requires liaising within numerous departments and staff. The scope of work will include: direct laboratory testing, product troubleshooting, strategy/test plan development, analytical method remediation activities, and impurity isolation/identification for a broad range of materials and product types. The Senior Analytical Chemist reports to the Supervisor - QAS and will be located on-site within the Amityville NY facility. ESSENTIAL FUNCTIONS:Include the following. Other duties may be assigned.Provide analytical chemical testing/laboratory work in support of the QAS department, Operations and Quality where required for commercial product support including but not limited to method development, method validation, product testing, degradation profiles, impurity identification, extractable leachable testing, and material contact studies. Material scope includes but is not limited to API, in process testing and finished drug products of the product forms noted in the company summaryIn coordination with other QAS personnel design investigation schemes to support commercial product troubleshooting and execute designed lab experimentsTroubleshoot and remediate analytical test methods for a wide range of API, excipients and finished productsDesign and execute test method developmentIn association with maintenance and analytical vendors as needed install, qualify and maintain the required laboratory equipment within the Technical Services laboratoryPerform the analytical laboratory work to serve as the sending lab for test method transfer as needed within Akorn sites, contract manufacturing facilities and contract laboratoriesDocument and maintain data/test results according to GMP. Produce reports and present results as required for management updatesOperate and maintain the QAS Laboratory within GMP and SOP requirements and within budgetPerform other duties as deemed necessary by department managementEnsure that all data comply with cGMP, FDA and/or other appropriate regulatory guidelines

Created: 2021-11-29