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Manufacturing Specialist - Severn

Company: Paragon BioServices, Inc.
Location: Severn
Posted on: July 15, 2019

Job Description:

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 Manufacturing Specialist will provide support for Manufacturing Management and Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Specialist will be responsible for, executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records. Must be willing to work overtime or shift work as required. Key Responsibilities include but are not limited to: Initiates Quality Records and conducts deviation investigations that meeting both Industry and Paragon expectations Leads or manage investigations including root cause analysis and assesses product impact using input from various departments Develops, executes and oversees CAPAs Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective. Supports Tech transfer and process monitoring support as needed Works with the team to monitor critical process parameters Revision and management of manufacturing documents such as Batch Records and SOPs Leads or supports Continuous Improvement projects Conducts data gathering, trending, and data presentation as needed to support investigations Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report. Education & Experience: Bachelor's degree in a science or engineering field and 5+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field) Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment Previous experience in process deviation investigations and remediation Previous experience authoring and/or revising technical documents Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget Excellent communication and technical writing skills Ability to support and/or lead system troubleshooting efforts Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities 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. #LI-EW1

Keywords: Paragon BioServices, Inc., Baltimore , Manufacturing Specialist - Severn, Other , Severn, Maryland

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