Manufacturing Support Services III Associate
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Manufacturing Support Services III Associate

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 Manufacturing Support Services III Associate will be responsible for performing routine cleaning and assembling activities that aid in the production of gene therapies. The incumbent will be responsible for supporting the manufacture of viral vectors, non-viral vectors, and advanced therapeutics while maintaining compliance to cGMP standards. This position will participate in the onboarding and training of the inaugural manufacturing support services staff for the stand up of a new organization.

We are looking for individuals that have experience working within a team, are hard-working, highly motivated, 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 lead role. 

Responsibilities

  • Work in a hands-on capacity to prepare buffers, assemble jumper harnesses, and clean/sterilize equipment and materials.
  • Work closely with manufacturing personnel by transferring/stocking critical materials and delivering samples throughout the facility.
  • Clean GMP spaces, collect waste from production suites, and perform decontamination protocols.
  • Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
  • Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Assist in the resolution of manufacturing support deviations/non-conformances and troubleshooting of support process and equipment problems.
  • Assists with training other manufacturing support services associates.
  • Assist in validation activities related to the qualification of the manufacturing support process, facility suites, and support equipment.

Education & Experience

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A minimum of 3-5 years of experience in cGMP biological manufacturing. Contract, Development, and Manufacturing Organization (CDMO) experience preferred.
  • Strong knowledge of cGMP regulations.
  • Experience working in a Biological Safety Cabinet (BSC).
  • Strong written and verbal communication skills, with excellent teamwork aptitudes.
  • Experience working with autoclaves, washers, aseptic operations, and cleanroom decontamination procedures is highly preferred.
  • Demonstrated ability to troubleshoot and resolve equipment and processing issues.
  • Strong knowledge of process validation practices.
  • Proven efficiency working in a Biological Safety Cabinet (BSC).
  • Experience working with pipettes, micropipettes, and scales.
  • Experience working with decontamination practices for materials and liquids.
  • Experience handling and formulating cleaning solutions.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows eagerness to learn and problem-solve.
  • Innovative and efficient when solving problems with a focus on continuous improvement.
  • Possesses technical aptitude to learn and operate production equipment.
  • Able to adhere to all safety and company regulations.
  • Able to accommodate a flexible work schedule to support business demands.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.

Compensation: TBD

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