Process Engineer
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Process Engineer

King of Prussia, PA

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Summary

The Process Engineer will be heavily involved in managing the manufacturing and production systems for gene therapy operations. They are responsible for implementation of process platforms that are well characterized, efficient, scalable and that produce high-quality products in GMP and development environments. This entails requirements gathering, specifications development, validation support, troubleshooting and identification of continuous improvement projects on production products and processes.

Responsibilities

● Work with a cross-functional team of scientists, automation engineers, facilities staff, and operations experts to develop, deploy, and rapidly improve process manufacturing solutions in a fast-paced startup environment.

● Support facility/equipment commissioning and qualification as appropriate.

● Partner with manufacturing, facilities, quality, and process development to ensure successful manufacturing facility start up.

● Design and execute data gathering studies for new and existing protocol preparation.

● Create analytical tools in order to better understand our instruments and processes.

● Provide technical support and guidance to maintenance, metrology and facilities management groups.

● Develop procedures for technology transfer activities for transition of new products and processes from R&D to production and GMP manufacturing.

● Identify areas for technological or process improvement and lead multi-disciplinary teams to implement these changes.

● Support facility design and capital project execution projects with process input.

● Maintain expertise on technology advancements in cell and gene therapy production processes, equipment, instrumentation and systems.

Qualifications

  • B.S. or M.S. in a Life / Physical Science or Engineering (equivalent experience will be considered).
  • 3+ years experience in design, development, implementation and improvement of biopharmaceutical manufacturing processes and systems.
  • Familiar with design specification and operation of bioprocess equipment, clean utilities and GMP facilities.
  • Ability to apply technical knowledge in a physical operating environment.
  • Knowledge of MS Project, Visio, Team and Office suite of software is a must.
  • AutoCAD design and Bluebeam Revu PDF editing experience is a plus.

Compensation: TBD

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