Supervisor, Quality Control - 2nd Shift

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 is a 2nd shift position

This individual is responsible for supervising routine QC testing on cleaning, in-process and release samples. The individual will also assist analytical method transfers and method qualifications between the Analytical Development group and Quality Control (QC). The Quality Control Analytical Supervisor must demonstrate strong technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

Key Responsibilities include but are not limited to:

• Oversight and maintenance of Paragon's quality control analytical testing program (including assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis)
• Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, ddPCR, HPLC and Capillary Electrophoresis
• Generate internal and external documents such as assay protocols, summary reports, and SOPs
• Provide instrumentation care, maintenance, troubleshooting, and data interpretation
• Work closely with Manufacturing and Quality 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
• Ensures compliance with cGMP and safety requirements within the QC analytical laboratory
• Participates and carries out continuous quality improvements in the QC laboratory
• Participates in project specific, system, client, and vendor audits
• Maintains QC analytical laboratories and facilities in an audit ready status at all times.
• Conducts training on applicable SOPs, regulatory requirements and quality initiatives
• Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.
• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels
• Ability to work within a team setting as well as independently

Education & Experience:

• Bachelor in a Life Sciences discipline or equivalent experience is a minimum requirement
• 5 or more years of relevant experience and at least 2 years of management experience in GMP regulated laboratory preferred
• Considerable knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology
• Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices
• Experience in writing SOPs and test methods as well as method qualification/validation documentation
• Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work
• 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.

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