Sr. MS&T Specialist - Process Engineer
Paragon Bioservices, Inc. (PBI) is a growing biopharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
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. Specialist 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.
Has considerable knowledge/expertise relevant to protein and virus manufacturing in a cGMP environment. Knowledge/expertise should be hands-on and focused on tech transfer activities:
- Experience in: aseptic technique, cell and/or microbial culture, virus production, protein purification, single-use bioreactors, clarification modes, chromatography and good manufacturing practices (cGMP).
- Able to draft Tech Transfer Documents, Process Flow Diagrams, batch records, SOPs, and specs for routine productions
- Proven experience in a CMO environment or in a similar client-customer based work environment
- Effectively communicates results of own work to clients and internal groups though discussions and documentation.
- Able to work in team oriented environment working closely with clients, Project Management, Process Development, GMP manufacturing and Quality.
- Interacting with external and internal clients as the MS&T lead to communicate project details.
- Preparing tech transfer documents, including detailed process descriptions and scale-up documents
- Work with GMP manufacturing and Process Development as SME in one or more of the following areas: cell culture, purification and/or fill & finish
- 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, batch manufacturing records and protocols in support of Tech Transfer and cGMP activities.
Experience & Education:
- B.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 10+ years of experience in the pharmaceutical or biotechnology industry -OR-
- M.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 6+ years of experience -OR-
- Ph.D. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 2+ years of experience
- Experience must include aseptic technique, cell and/or microbial culture, virus production, protein purification, chromatography and good manufacturing practices (cGMP).
- Experience with external client interaction 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.