Process Science Associate III Tech Transfer 10/8/2017
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 Science Associate III Tech Transfer responsible for the technical transfer and implementation of manufacturing processes. The Associate III leads technology transfer projects from planning through execution, and provides adequate training and support for GMP personnel in the implementation of new processes.
Conducts experiments in Process Science laboratory following protocols and accurately documents procedures and results in laboratory notebook under minimal supervision.
Completes analytical testing as needed to support manufacturing activities under minimal supervision.
Responsible for preparing components, media, buffers, and other solutions as needed.
Responsible for performing routine maintenance of laboratory equipment.
Performs data analysis, and prepares results summaries under minimal supervision.
May attend client meetings and presents experimental results and data summaries.
May be responsible for preparing training documentation and presentations for new methods and technologies to enhance operations.
Provides technical support for GMP personnel in the implementation of new and modified processes under minimal supervision.
Cross-trains and/or focuses on various tasks including upstream and downstream GMP manufacturing under minimal supervision.
Responsible for completing, and may train junior members, with SOP and GMP training, adhering to GMP policies and procedures with and ensuring accuracy through exceptional attention to detail.
May train other personnel and/or oversees the execution of activities.
Scales-up upstream and downstream manufacturing processes for large scale plasmid and protein production under minimal supervision.
May assist in preparing Technology Transfer Protocols and Reports and preparing project presentations.
May assist in authoring Engineering Run batch records; reviewing and approving GMP batch records and SOPs.
May be responsible for authoring and/or reviewing GMP-related documents such as material specifications, buffer batch records, deviation reports, as required.
May be responsible for training GMP personnel in the implementation of new production and manufacturing procedures.