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.