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 Director, MS&T is a leadership role responsible for ensuring the robust execution of Mammalian, Microbial, Gene Therapy and Viral Vaccine platforms developed and transferred into cGMP Manufacturing. The Director, MS&T is responsible for leading a team of MS&T leaders & MS&T Engineers and to be the process owner and technology transfer lead for Upstream and/or Downstream biologic drug substance and formulation and aseptic fill finish processes. The individual will work closely with Client, Process Development, Manufacturing, and Quality to ensure successful implementation of cGMP drug substance and drug product manufacturing 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:
- Strategic client facing leader of the MS&T team on behalf of the organization
- Leadership of multi-level teams including managers and engineers
- Work with GMP manufacturing and Process Development as SME 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.
- Author technical reports, process tech transfer summary reports, and protocols in support of Tech Transfer and cGMP activities
- Train GMP Manufacturing staff on Client processes
- Serve as team leader for process and product investigations and author investigation reports
- Evaluate, recommend and procure equipment for client projects
Education & Experience:
- B.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 12+ years of experience in the pharmaceutical or biotechnology industry -OR- M.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 10+ years of experience -OR- Ph.D. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 8+ years of experience
- Previous supervisory and/or team management experience
- 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.