Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference.
Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love.
Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.
The Quality Control Analyst is responsible for routine QC raw material, in-process and product testing and stability testing as well as testing of cleaning and validation samples to support Phase I/II/III and Commercial GMP manufacturing.
The QC analyst must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.
Paragon has 3 shifts in operation: 1st shift: 8:00 am - 4:00 pm 2nd shift: 4:00 pm - midnight 3rd shift: midnight to 8:00 am Key Responsibilities include but are not limited to: Has basic knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology.
Knowledge/expertise should be practical and focused on lab-related activities: Perform routine testing such as filter integrity testing, TOC, pH, conductivity and HPLC.
Experience with ELISA testing preferred but not required.
Generate testing records and report results Provide instrumentation care, maintenance, troubleshooting, and data interpretation Work under general supervision to meet project goals Work closely with Manufacturing andQuality Assurance staff to resolve quality issues with regard to the facility and products manufactured Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.
Experience & Education: B.S.
in a Life Sciences discipline and 1-4 years of experience in a GMP QC laboratory performing routine testing such as filter integrity testing, TOC, pH, conductivity and HPLC required.
ELISA testing preferred Experience in writing SOPs and test methods Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks Ability to succeed in a team-oriented environment under very dynamic conditions Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.