Quality Control Analyst - Cell Culture

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.

This role is responsible for Quality Control Cell Culture testing to support Phase III/Commercial GMP manufacturing operations and Drug Substance/Drug Product release. Works in a fast-paced environment supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance and sterile finished drug product.

Position workweek is Monday through Friday.

Key Responsibilities include but are not limited to:

• Perform adherent and cell culture testing in a Phase III/Commercial GMP Manufacturing facility. Includes but is not limited to: thawing, enumeration, passaging and cryopreservation of various cell line types required for QC assays.
• Documents all testing data in accordance with cGMP/GDP requirements
• Provide support to analytical/process development to onboard new client assays or enhancement to the testing capabilities of the cell culture laboratories.
• Provides input on SOP revisions and may assist in the creation and editing of protocols
• Builds credibility within the lab group by performing high quality work
• Works closely with manufacturing and QA to coordinate cell culture activities required to support manufacturing operations and product release activities
• Report and investigate OOS/OOT or other deviations from approved procedures/processes.
• Effectively communicates results of own work through discussions and documentation with some input from supervisor
• Flexibility in following unique campaign requirements that may include off-hour and weekend work
• Other duties as assigned, may be required to cross train to support QC microbiological and analytical chemistry testing

Experience & Education:

• A.S. in a Life Sciences discipline and 1-4 years of relevant experience working in GMP clean rooms performing cell culture testing
• Experience with aseptic techniques
• Experience with Microsoft Office
• Strong attention to detail
• Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

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.

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