CBM

Full Time EE

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.

Summary

The Cell Therapy Bioengineering Associate will be responsible for performing routine processes for the manufacture of human blood derived cell therapies in a controlled, cGMP cleanroom environment of a multi-product facility. The incumbent will be responsible for operating equipment for autologous and allogeneic cell therapy processes and performing lab support activities while maintaining compliance to cGMP standards. The successful candidate will play a key role in establishing internal standards for onboarding and training of new cell therapy team members while establishing best practices that will become standards of procedure for the cell therapy organization. We are looking for an individual that has experience working within a team, is hard-working, self-motivated, results-driven, and solution-oriented. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a higher-level associate.

Responsibilities

Work cross-functionally in a hands-on capacity utilizing aseptic technique to perform cell culture processes through cell culture, harvest, and cryopreservation and lab support activities within a cleanroom environment. • Ensure work is completed in compliance with controlled documentation (SOPs, batch records, forms, etc.) and all applicable guidelines, safety policies and procedures are followed. • Become fully trained and qualified in all aspects of assigned processes. • Maintain manufacturing facility in a cGMP status and ensure a continued state of inspection readiness. • Adhere to the schedule ensuring manufacturing logistics are maintained on time. • Establish a broad level of technical knowledge of cell therapy processes. • Record process data and information in a clear/concise format according to proper GDPs. • Establish a broad level of comfort working with basic lab equipment, specific Cell Therapy process equipment, and manufacturing logistics systems. • Author and revise documents for equipment and processes, when applicable. • Perform tech transfer activities related to new product introduction to the manufacturing facility. • Assist in the resolution of manufacturing deviations of process and equipment problems

Demonstrate a positive attitude within the team and proven ability to complete assignments on time.

Education & Experience

Bachelor’s degree in biological science(s) field or related engineering is preferred but not required. • A minimum of 1-3 years of experience in cGMP biological manufacturing. Cell therapy manufacturing is highly preferred. • General understanding of cell culture, cryopreservation, and aseptic processing/technique. • Strong written and verbal communication skills, with excellent teamwork aptitudes. • General knowledge of cGMP and FDA regulations. • Basic mathematical skills and technical writing capabilities.

MS Office Experience

Physical Demands

Ability to carry up to 55 pounds. • Ability to stand for long periods of time while wearing PPE. • Ability to work weekends/off-shift hours, when applicable. This position has the possibility to evolve into a second shift or off-shift position.