Manufacturing Associate

As part of manufacturing plants Purification team, the Manufacturing Associate is responsible for executing purification processes and ancillary tasks related to the production of Obizur, a commercial biologic treatment for Acquired Hemophilia-A. The Manufacturing Associate works in strict compliance with cGMP regulations and all applicable company regulations.

In this hands on position, operate process equipment in downstream manufacturing performing processes such as (1) Column packing and qualification, column chromatography, depth filter clarification, nanofiltration and drug substance dilution, (2) Automated and manual chromatography skid systems, filter systems and mixing systems. * Operate BSCs, microscopes, incubators, mixing equipment, pH meters, conductivity meters, autoclaves, and other support equipment. * Cleans equipment and parts for use in CGMP operations using manual systems and a Glassware washer. Prepares equipment and assemblies to be autoclaved. * Independently complete required documentation and may guide other operators on proper GMP recording of entries and comments in batch records, forms and protocols. * Perform real time Production Batch Record review prior to submission to supervisor. * Clean equipment and parts for use in cGMP operations using manual systems and Glassware washer. Prepare equipment and assemblies to be autoclaved. * Lead/participate in 5S and Lean initiatives including tracking metrics, posting on visibility boards, communicating program updates to personnel at all levels of the organization

EDUCATION AND EXPERIENCE HS diploma with 5-7 years of related work experience in a GMP environment; or, AS degree with 3-5 years of related work experience; or, Bachelors degree with minimum of 1-3 years of GMP biologics manufacturing experience. Degree in a scientific discipline preferred. The following attributes are also essential to this position: * Attention to Detail - being careful about detail and thorough in completing work * Adaptability/Flexibility - being open to a variety of schedules according to changes in production * Dependability - being reliable, responsible and fulfilling obligations especially in regards to working in a team environment

Technical Knowledge * Production/Processing - Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture of pharmaceutical products. Includes knowledge of aseptic technique and basic lab instruments, (pH Meter, Conductivity Meter, Scales, etc.) * Safety/Security - Knowledge of relevant equipment, policies and procedures to promote effective and safe operations for the protection of people, data and company property

About Aerotek:

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Aerotek is acting as an Employment Agency in relation to this vacancy.