Vector Upstream Bioprocessing Lead Associate SECOND SHIFT

King of Prussia

Summary

This role is supporting second shift

The Vector Upstream Bioprocessing LeadAssociatewillserve as arole model to leada diverse teamtowards achievingon-time delivery ofmanufacturing operations by performingroutine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the genetherapy asset at the Center for Breakthrough Medicines. The incumbent willembrace and promote right-first-timeculture whileoperatingupstream equipmentfor adherent and suspension systemsand performing production support activities while maintaining compliancetocGMP standards.

We are looking for individualsthathave experience as a goal andsolution-oriented team player, arehard-working, highly motivated,andeager to contribute to building a manufacturing operation. The individual will alsohave a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functionalteam andshowcommitment to the highest safety and quality standards.This position requires multi-tasking,interdepartmental coordination,and excellentpeer-to-peercommunicationskills. This positionhas the potentialtoevolve into a supervisor role.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment toperformcell culturescale-up and operatesingle use bioreactors.
  • Leadand motivateoperational staff on a daily basis bypromotinga culture. ofinclusiveness,safety, continuous improvement,training objectives, and compliance.
  • Assist in maintaining thecGMP status of the manufacturing facilitytoalways 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 ofprocess andequipmentproblems.
  • Provides timely technical input to support ongoing operations.
  • Assistwith on-the-floor reviewofbatch records in real time.
  • Assist in the development oftraining materialtosupport the initial and ongoing training of manufacturing personnel.
  • Identify opportunities for improvements in process, safety, quality, and cost.
  • Lead trainingofnewBioprocessing associates.
  • Leads initiative to assist in validation activitiesrelated tothe qualification of themanufacturing process, facilitysuites, andprocessequipment.
  • Acts as qualified trainer for SOPs and procedures in functional area.

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.
  • A minimum of 1-3 years of leadership experience is preferred.
  • Experience working with single-use bioreactors, aseptic operations, cell culture, and seed scale-up.
  • 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 incubators, pipettes, and micropipettes.
  • Demonstrated ability working with sterile tube welders, sterile tube sealers, and cell counting machines.
  • Experience working with of cell expansion vessels such as T-flasks or shake flasks.
  • 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 single-use bioreactors, aseptic operations, and seed scale-up 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 scheduleto support business demands.
  • Strong written and verbal communication skills, with excellent teamwork aptitudes.

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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