Vector Drug Product Bioprocessing Associate III

King of Prussia

Summary

The Vector Drug Product Bioprocessing III Associate will be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines. The incumbent will be responsible for operating aseptic filling equipment and performing production support activities while maintaining compliance to cGMP standards. This position will participate in the onboarding and training of the inaugural manufacturing staff for the stand up of a new organization. May be required to support other areas of manufacturing when aseptic filling is not ongoing.

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 within a cleanroom environment to perform aseptic filling, inspection, labeling, and packaging of Drug Product.
  • 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 deviations/non-conformances and troubleshooting of process and equipment problems.
  • Assists with the training of Bioprocessing associates.
  • Assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.

Qualifications

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A minimum of 3 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly 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 aseptic filling equipment and isolators is preferred.
  • Demonstrated ability to troubleshoot and resolve equipment and processing issues.
  • Strong knowledge of process validation practices for biopharmaceutical products.
  • Proven efficiency working in a Biological Safety Cabinet (BSC).
  • Experience working with pipettes, and micropipettes.
  • 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.

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 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.

Physical Demands

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