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Latitude, Inc. Manufacturing Technician (GMP/Bio-Pharma) in Clarksburg, Maryland

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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