QC Analyst II-Microbiology

Job Listing No: 9740000

QC Analyst II-Microbiology

Details: Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases associated with central nervous system (CNS) disorders such as addiction, schizophrenia, and depression. As a fully integrated global biopharmaceutical company, Alkermes applies our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. In order to support the rapid growth of the Wilmington site and overall company vision, we are seeking a highly motivated and energetic Microbiologist to join the Commercial and Clinical Product Testing group within the Microbiology department. The group is responsible for testing and support activities for our long-acting and nanoparticle technology platforms which are utilized for the manufacturing of sterile injectables. The group also provides microbiological support to Alkermes development pipeline products which includes Biologically Derived Products and Oral Solid Dosage forms. Alkermes is in the final stages of an extensive renovation of their microbiology laboratories and the procurement of new technologies to support our sterile and aseptic manufacturing processes. In addition to support of the testing and release of commercial and clinical products, the Microbiologist will help with evaluating and commissioning new laboratory equipment and the development and validation of test methods to support the expansion of manufacturing operations. Summary The Microbiologist is familiar with all techniques within the laboratory required for the routine support of laboratory operations. In this role the Microbiologist will be a fully functional member of the team responsible for testing, data entry and review of commercial and clinical materials. Additional responsibilities will require collaboration with appropriate internal and external partners, planning and writing Protocols and Reports to support instrument/equipment qualification and microbiological method validation activities. Working with the laboratory Supervisor, they will coordinate and execute project actions. The Microbiologist is a competent and approachable trainer, who is required to provide training on new methods and equipment. The microbiologist aids in the development of SOPs for the equipment or methods they qualify. The Ideal Candidate will have the following primary qualifications, experience and attributes BSc In science related field with (min) 6 years’ experience in pharmaceutical manufacturing Experience with the execution and validation of microbiological test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters Critical thinker, ability to identify issues and work quickly to resolution. Able to approach novel testing issues and develop compliant, cGMP solutions. Capable of managing/coordinating multiple projects and priorities in a dynamic environment, while maintaining a professional demeanor. Strong technical knowledge of microbiological test instrumentation and method development / validation. Excellent organizational, planning and scheduling skills Good verbal and written communication skills; confident presenter, clear, concise technical writer. Experience of Thermo Sample Manager LIMS or other LIMS system. The primary responsibilities of the position are: Testing, data entry and review of commercial and clinical materials. Write or review investigation reports and other forms required by the investigation procedure. Lead specific aspects of a project and guide solutions for difficult problems. Identify best solutions based on project requirements. Write, revise or review SOP’s, analytical protocols, analysis reports, specifications, and controlled forms Serve as subject matter expert on operation and troubleshooting of select laboratory instrumentation.

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