Working with a number of Bio-Tech and Pharmaceutical organizations who are looking for Manufacturing Techs and Professionals.
Senior Manufacturing Associate will be responsible for duties, such as:
- Direct downstream cGMP processing: facility, buffer preparation, and protein purification (primarily antibody)
- Responsible for working with junior associates in all cleanroom GMP activities
- Assist in developing junior staff capabilities, creating a culture of safety, maintaining training objectives, compliance and collaboration while implementing process improvements where applicable
- Batch record, SOP, and inventory compliance with QA and Material Control
- Understand QA/QC compliance: deviation management, training, cGMP compliance
EDUCATION AND QUALIFICATIONS:
- Demonstrated experience with cGMP-compliant downstream processes, notably in the area of antibody purification
- Experience with buffer preparation, large volume preparation (50L – 200L)
- Familiarity with basic biochemistry concepts: pH, conductivity, solution concentrations, column chromatography, protein concentration determination, etc.
- Experience with the AKTA process chromatography system (Unicorn software); column chromatography at the 6L to 30L bed volume scale
- Experience in BPG column pouring and qualification
- Experience with maintaining and executing cGMP-qualified protocols (batch records) and SOP’s; cGMP documentation
- Assist with junior staff oversight; Experience with mentoring junior staff a plus
- Responsible for all cleanroom GMP activities
- S. (or higher) in life sciences with at least 5-10 years relevant industry experience
- B.S. or higher in Life Sciences with at least 5-10 years relevant industry experience
You’ll have responsibilities in contributing to essential supply inventory, and to ensure compliance with current Good Manufacturing Practices (cGMP), policies and safety practices for your team.
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Posting ID: 593997023Posted: 2021-01-25