Vector Drug Product Bioprocessing Associate I

King of Prussia

Summary

The Vector Drug Product Bioprocessing I Associatewill be responsible for performing routine cGMP aseptic filling 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 fillers and isolators and performing production support activities while maintaining compliance to cGMP standards. In addition, operators will perform visual inspection of finished product.Operators will be expected to assist in other areas when Drug Product fills are not occurring.

We are looking for individuals that are willing to work within a team, are hard-working, and highly motivated. This position requires multi-tasking and excellent peer-to-peer communication skills.

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.
  • 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 range of 0-2 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
  • General knowledge of cGMP regulations.
  • Experience working in a Biological Safety Cabinet (BSC).
  • General knowledge of aseptic filling equipment and isolators.
  • Ability to work well independently and as part of a team.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows willingness to learn and problem-solve.
  • Willingness 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 range of 0-2 years 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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