Advanced Research Associate GMP
Job Details
Experienced
Minneapolis, MN - Minneapolis, MN
Full Time
Bachelor's Degree
Negligible
Day
Research
Description

Job Duties:  The responsibilities of this position are to manufacture protein purification reagents/kits to restock the supply of existing products and modify and validate existing protocols for larger scale production of these reagents/kits. Duties include: Perform expression and purification of proteins for restock utilizing High Performance Liquid Chromatography method in the AKTA system; analyze biological data to and make decisions to create a process that delivers consistent product/process to meet quality and performance specifications; research protein purification protocol modifications for large-scale purification (process development); rewrite purification protocols after process modifications for process methods; implement Correction Action Preventive Actions (CAPA’s); conduct equipment calibration and maintain lab equipment including TFF (tangential flow filtration), pumps, chromatography columns, AKTA systems, aseptic filters, and bench equipment, concentrators, and pH meter, and contracts repair service when needed; maintain lab order and cleanliness; dispense and label reagent product; assist in raw material and product inventory control; prepare aseptic filter and aliquot product for bulk storage; prepare common buffers and reagents; improve operation efficiency and contribute to reducing costs; generate and maintain equipment validation and process SOPs (Standard Operating Procedures); develop and validate new Good documentation practices (GDP) and Current Good Manufacturing Practices (cGMP) for protein purification process development; work with supervisor and manager to facilitate scheduling of starting material; maintain compliance with the lab’s quality training and documentation; follow company policies and practices as outlined in the Handbook and follows safety guidelines according to the AWAIR (A Workplace Accident and Injury Reduction Program), Chemical Hygiene and Exposure Control manuals; Column chromatography; HPLC operations and mechanisms using AKTA system; process equipment including TFF, pumps, chromatography columns, aseptic filters, and bench equipment; writing processing protocols to purify proteins; generation and maintenance of process SOPs; good documentation practices (GDP) and Current Good Manufacturing Practices (cGMP); biological data analytics; corrective Action Preventive Action (CAPA’s); safety guidelines according to the AWAIR (A Workplace Accident and Injury Reduction Program), Chemical Hygiene and Exposure Control manuals.

This position will be required to work a Sunday-Thursday or Tuesday - Saturday work week.

Multiple positions available.

 

Qualifications

Requirements:  Bachelor’s degree in Biology, Biotechnology, or a related field with a minimum of 2 years of experience with protein purification or a Master’s degree in Biology, Biotechnology, or a related field with a minimum of 1 year of experience with protein purification.  Must possess 1 year of experience with each of the following: Column chromatography; HPLC operations and mechanisms using AKTA system; process equipment including TFF, pumps, chromatography columns, aseptic filters, and bench equipment; writing processing protocols to purify proteins; generation and maintenance of process SOPs; good documentation practices (GDP) and Current Good Manufacturing Practices (cGMP); biological data analytics; corrective Action Preventive Action (CAPA’s); safety guidelines according to the AWAIR (A Workplace Accident and Injury Reduction Program), Chemical Hygiene and Exposure Control manuals.

 

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