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Manager, Manufacturing Engineering
SeraCare Life Sciences, Inc. has served the global life sciences community, with distinction, for over 25 years. Headquartered in Milford, MA we have locations in Massachusetts and Maryland. We develop and manufacture the highest quality, biologically-based products and we offer a broad range of related OEM services, backed by expertise in virology, serology, immunology, and molecular biology.
Your mission: make life better.
Our mission: help you make life better.
Our Company Vision is to become the leading provider of human biologic reference materials to enable biomedical research; the development, manufacture and efficacy of laboratory diagnostics while providing critical tools to accelerate the realization of precision medicine.
At SeraCare, we care about our employees, and it shows, in the challenging opportunities, competitive salary, and comprehensive benefits package that we offer.
About the Role:
This position leads our Manufacturing Engineering Team (Project Managers). Primary responsibilities are prioritizing a changing array of projects in support of business flow, product design, validation, and transfer to manufacturing of new controls, test methods and assay components.
Our Manufacturing Engineering Manager serves as a technical liaison between the manufacturing teams, procurement group, product managers and customers. Position analyzes serological and nucleic acid test results throughout the process and is involved in establishing the scope of new product design controls (testing requirements and timelines), design goals, preparation of design failure mode effect analysis (FMEA), coordinates the deliverables, and creates MRF instructions detailing raw materials [biologics] and resources needed.
Ideal candidate must have proven experience working in the life sciences industry in the design and execution of pilot lot manufacturing with successful product transfer – acting as a bridge between operations and R&D. Must possess the ability to read and interpret ELISA and EIA test results and be able to direct the manipulation of the manufacturing process based on test results Must be highly collaborative internally & externally to provide high level of customer service. Should be proficient with Microsoft Office, specifically Microsoft Word and Excel.
Previous project management experience is a plus.
If you are strong effective leader, detail oriented, able to work within tight deadlines, energetic, possess strong computer and analytical skills, excellent communicator (verbal and written) who excels in project management – we would love to hear from you!
Must possess a minimum of 5 years relative experience and a Master’s Degree in Immunology or Virology. Training in cGMP, FDA and ISO regulations a plus.
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