Director, Manufacturing Process Engineering

Job Description
Director, Manufacturing Process Engineering

SeraCare has served the global life sciences community, with distinction, for 25 years. We develop and manufacture the highest quality, biologically-based products and we offer a broad range of related services, backed by expertise in virology, serology, immunology, and molecular biology. At SeraCare, we are inspired when our products and services accelerate or improve your critical processes of validation, discovery, and production.

Your mission: make life better.

Our mission: help you make life better.

Position Summary: Responsible for evaluating and validating existing procedures used in development and production of products as well as planning, designing and conducting process and methods development studies to generate new strategies, techniques and processes. Create related SOPís and train manufacturing staff appropriately on new procedures. Ensure all systems are operating according to specifications and within regulations to ensure the production of quality products. Ensure implementation of Master Validation Plan including execution of all aspects according to Validation Schedule. Execute validation plans and programs for new and improved manufacturing processes and products as well as implement QC and QA systems for new and existing manufacturing processes and products. Provide leadership and technical decision making for management regarding cGMP compliance, regulatory issues, validation strategy. Support new product development projects, OEM product design and development, and formulation and re-formulation of existing products from a process engineering perspective. Direct projects involving development of basic and advanced methods in protein and nuclei acid purification and characterization, reaction kinetics, conjugation chemistries, and design, validation and transfer to manufacturing of new controls, test methods and assay components. Collaborate with technical and marketing personnel and other internal and external resources regarding product design, budget planning, project planning and management of related outside vendors.

Qualifications: Must embrace working in a fast-paced, team-oriented, cross-functional environment. Masterís degree required in an Engineering discipline with the preference being Chemical, Mechanical or Biomedical Engineering, with a minimum of 8-10 years of management experience within the IVD, pharmaceutical, biotechnology or FDA regulated industry. Must have experience with equipment sanitary design principles and materials of construction used in the biopharmaceutical industry. Should also be knowledgeable with respect to one or more the following: aseptic processing and filling, lyophilization, capping, ultrafiltration, chromatography, centrifugation, filter press and other filtration systems, cGMP facility design (cleanrooms, ISO classes, HVAC), utility systems common to the medical device or biologics industry, clean-in-place (CIP) and steam-in-place (SIP) equipment and cycles, air-handling-units, autoclaves, clean room design and operating principles . Must be familiar with cGMPs, Good Engineering Practices, as well as FDA and EU regulations. Basic knowledge of programmable logic controllers (PLCs), DCS systems and instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is desirable.

Company

SeraCare Life Sciences, Inc.

Job Code

State or Province

Massachusetts

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