MS&T Engineer II/III

Paragon BioServices, Inc.
Baltimore, MD
Jul 21, 2019
Jul 23, 2019
Engineer, IT, QA Engineer
Full Time
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 position will support Manufacturing Operations in the successful transfer and startup of clinical drug substance and drug product cGMP manufacturing operations at Paragon Bioservices. The MS&T Sr. Engineer is actively engaged in the translation of client and Paragon Process Development information for implementation of cGMP processes. The individual will serve as a subject matter expert (SME) for biologic Upstream Processes and/or Downstream Processes. Success in this position requires the ability to work hands on in a cleanroom, and the ability to collaborate in a cross-functional, fast paced environment. Key Responsibilities include, but are not limited to: Work with GMP manufacturing and Process Development in one or more of the following areas: cell culture, purification and/or fill & finish Support client projects as the MS&T Lead for tech transfer of projects from Paragon Process Development and external clients into GMP manufacturing. Author tech transfer documents, including detailed process descriptions and scale-up documents Author Master Production Records and SOPs to support GMP manufacturing projects Working closely with project management to ensure MS&T project milestones are achieved Collect and trend process data for external (client) and internal review, and for support of client needs. With support of senior staff, draft technical reports, process tech transfer summary reports, and protocols in support of Tech Transfer and cGMP activities Assist with training GMP Manufacturing staff on Client processes Serve as team leader for process and product investigations and author investigation reports Evaluate and recommend equipment for client projects Education & Experience: BS Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 3-5 years of experience in the pharmaceutical or biotechnology industry Knowledge/expertise relevant to protein and virus manufacturing in a cGMP environment. Experience in one or more of the following manufacturing areas: cell and/or microbial culture, protein purification and fill/finish Experience in a CMO environment or in a similar client-customer based work environment a plus 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

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