Senior Quality Control Research Associate II

4 weeks ago

Wilmington, Ohio, United States Alkermes Full time
Job Description Background

Alkermes is seeking a highly motivated and knowledgeable Senior Quality Control Research Associate II to join its QC Technical Services group. The successful candidate will be responsible for all Microbiological/Chemistry related projects across multiple sites, including but not limited to the identification and procurement of new equipment/technologies, coordinating feasibility studies, method development and validation of methods, supporting investigations for manufacturing, writing and reviewing regulatory sections for INDs, BLA, NDA, sNDA, and other regulatory supplements, and supporting audits for regulatory agencies and customers.

Position Summary

The Senior Quality Control Research Associate II must be a competent professional who is able to network with internal colleagues and external vendor representatives, consultants and other professionals. Using this network and their own experience and expertise, they are able to develop creative and compliant solutions to challenges. They must be familiar with the common techniques and equipment within a pharmaceutical laboratory and the regulation and guidance that govern them. As the Subject Matter Expert on laboratory equipment and methods, they must be an approachable and experienced trainer capable of clearly articulating technical details.

Responsibilities

The Senior Quality Control Research Associate II will be responsible for providing strong scientific and validation input for all projects within the Microbiology/Chemistry Technical Services group, e.g., implementation of instrumentation, method transfers and validations, and other compendia tests. This position requires cross-functional collaboration with other departments including Manufacturing, Process Development, Validation, and Quality to provide support of site validation studies, microbial studies, and new product(s) implementation.

Requirements

The ideal candidate will have a BSc in a science-related field with 4+ years' experience in pharmaceutical manufacturing or equivalent. They must be able to work autonomously, receiving general instructions on new assignments. Strong technical knowledge of microbiological/Chemistry test instrumentation and method development/validation including software/computer system validation is required. Experience with the execution and validation of test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing is also necessary. Knowledge of current compendia requirements is essential. Excellent organizational, planning and scheduling skills are required, as the candidate will be responsible for managing/coordinating multiple projects and priorities in a dynamic environment while maintaining a professional demeanor.

Personal Attributes

The successful candidate will be a motivated self-starter, a team player, committed to quality, well-organized, efficient, and a good problem solver. They will be a critical, analytical thinker, able to manage multiple duties and projects, and a creative, innovative thinker who is easily adaptable to change. They will bring closure to work in a timely manner and be able to learn from mistakes and hold a strong belief in continuous improvements, both personally and professionally.

About Us

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. As a fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients.

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