Vector Drug Product Bioprocessing Lead Associate

King of Prussia

Summary

The Vector Drug Product Bioprocessing Lead Associate will serve as a role model to lead a diverse team towards achieving on-time delivery of manufacturing operations by 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 embrace and promote right-first-time culture while operating aseptic filling equipment and performing production support activities while maintaining compliance to cGMP standards. May be required to support other areas of manufacturing when aseptic filling is not ongoing.

We are looking for individuals that have experience as a goal and solution-oriented team player, are hard-working, highly motivated, and eager to contribute to building a manufacturing operation. The individual will also have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team and show commitment to the highest safety and quality standards. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a supervisor role.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment to perform aseptic filling, inspection, labeling, and packaging of Drug Product.
  • Lead and motivate operational staff on a daily basis by promoting a culture. of inclusiveness, safety, continuous improvement, training objectives, and compliance.
  • 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.
  • Proactively assist in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
  • Provides timely technical input to support ongoing operations.
  • Assist with on-the-floor review of batch records in real time.
  • Assist in the development of training material to support the initial and ongoing training of manufacturing personnel.
  • Identify opportunities for improvements in process, safety, quality, and cost.
  • Lead training of new Bioprocessing associates.
  • Leads initiative to assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.
  • Acts as qualified trainer for SOPs and procedures in functional area.

Qualifications

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A minimum of 5 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
  • Experience working with aseptic filling equipment and isolators.
  • Advanced knowledge of cGMP regulations.
  • Proven ability to troubleshoot and resolve equipment and processing issues.
  • Advanced efficiency working in a Biological Safety Cabinet (BSC).
  • Demonstrated ability working with pipettes, and micropipettes.
  • Demonstrated ability working with aseptic filling equipment.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Exhibits extreme 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 strong focus on continuous improvement.
  • Possesses sound technical aptitude to learn and operate production equipment.
  • Advanced experience working with aseptic filling equipment is highly preferred.
  • Ability to teach, lead and mentor co-workers.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Able to accommodate a flexible work schedule to support business demands.
  • Strong written and verbal communication skills, with excellent teamwork aptitudes.

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 5 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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