Process Development Associate 8/27/2016
Ajinomoto Althea, Inc.
San Diego, CA
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Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.
Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.
Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.
Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.
Althea is currently seeking a Process Development Associate who will be responsible for the development, optimization and scale-up of downstream manufacturing processes for large scale plasmid and protein production in microbial systems including E. coli and yeast. This role will also be expected to train and support GMP personnel in the implementation of new and modified processes.
Assists in the development of scalable processes with improved product yield and reduced costs for manufacturing systems.
Conducts experiments in Process Development laboratory following protocols and accurately documents procedures and results in lab notebooks. Drafts experimental protocols and executes experiments under supervision.
Performs data analysis, and prepares results summaries and reports.
Authors and/or reviews GMP batch records and SOPs, as required.
May author and/or review GMP-related documents such as material specifications, deviation reports, as required.
Prepares components, media, buffers, and other solutions as needed.
Responsible for maintaining laboratory, including supplies inventory, glass wash and waste disposal under EH&S guidelines.
Responsible for routine maintenance of laboratory equipment.
May cross train and/or focus in various tasks including upstream and downstream GMP manufacturing. Remains current in GMP training and maintains GMP environment when working in manufacturing suites.
Completes analytical testing as needed to support manufacturing activities.
Assists in training GMP personnel in the implementation of new production and manufacturing procedures. May train new personnel in Process Development.