MANUFACTURING / PROCESS ASSOCIATE Mission Statement:
Responsible for the hands on execution of tasks related to the GMP manufacture of biopharmaceuticals. Assist or perform routine procedures following written instructions (SOPs, batch records, ETC.) in support of manufacturing intermediate, bulk or final drug product of acceptable quality to meet FDA and/or EMEA regulatory requirements. Responsibilities include: - Performance and documentation of all activities in compliance to GMP's
- Maintenance, preparation and cleaning of manufacturing areas, equipment, lab-ware and materials
- Preparation of solutions, media and other process related items in support of manufacturing processes
- Collection of in-process samples for pH, conductivity and temperature, etc. in support of manufacturing processes
- Operation of manual, semi-automated and automated equipment used for the production of biopharmaceuticals in cell culture and / or purification
Assembly/disassembly of manufacturing equipment for product changeover procedures - Write and revise SOP?s under supervision
- Assist in the execution of process, equipment and cleaning validation
Qualifications: - BS in Scientific/Engineering
- 2-5 years experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience
- Ability to work in fast paced, dynamic environment
- Attention to detail
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