Vector Drug Product Bioprocessing Associate II

King of Prussia

Summary

The Vector Drug Product Bioprocessing II 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.May be expected 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, and highly motivated. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a senior 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.
  • 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 2 year of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
  • Working knowledge of cGMP regulations.
  • Experience working in a Biological Safety Cabinet (BSC).
  • Effective written and verbal communication skills, with excellent teamwork aptitudes.
  • Experience working with aseptic filling equipment and isolators is preferred.
  • Experience working with pipettes, and micropipettes.
  • 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 ability to learn and problem-solve.
  • Exhibits 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 2 year of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy 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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