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Vector Manufacturing Supervisor

King of Prussia, PA, US
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Summary

The Vector Manufacturing Supervisor will be responsible for helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of vector upstream and downstream manufacturing. The incumbent will lead, guide, and train a diverse manufacturing team 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.

We’re looking for an individual who is a motivated self-starter and eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise. The individual should also have a willingness and aptitude for adoption of new technologies, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards. This position has the potential to evolve into a manager role.

Responsibilities

  • Ensure high levels of communication with the team, support resources, and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
  • Oversees the manufacturing process, supervises upstream and downstream processing on the floor, and delegates daily work assignments.
  • Lead, motivate, and develop manufacturing personnel by promoting a culture of inclusiveness, safety, continuous improvement, training objectives, and compliance.
  • Understands and performs aseptic technique and identify unacceptable practices and can make spot corrections to performance.
  • Ensures work is completed in compliance with approved SOPs, batch records and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Understands, trains, and coaches others on all operations, functions, and capability of equipment and is able to perform complex troubleshooting.
  • Identifies, suggests with options, recommends path forward and leads complex decision-making sessions.
  • Possesses basic and fundamental engineering and mechanical knowledge and is able to apply that knowledge in the manufacturing area, demonstrating unit operational and end-to-end understanding.
  • For escalations, works closely with the production staff to troubleshoot process and equipment
  • Responsible for maintaining the Vector Manufacturing facility and equipment to ensure constant compliance
  • Work closely with Quality Assurance and SPCI in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
  • Complete same-day review of completed batch records.
  • Oversees and adjusts training programs within the team, ensuring that manufacturing personnel are current on training requirements.
  • Proactively identify opportunities for improvements in process, safety, quality, and cost.
  • Train manufacturing and other team members on manufacturing procedures and especitc techniques, quality systems and compliance, and other operations required for cGMP manufacturing.
  • Assist in building out a full team of Vector Bioprocessing Associates at varying levels
  • Support CBM culture of “Be Committed, Ignite Innovation, Respect All, Embrace Customers, Empower Small, and Always be All In”.

Qualifications

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A minimum of 4 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
  • A minimum of 1-2 years of leadership experience is preferred.
  • Advanced experience working with single-use bioreactors, aseptic operations, cell culture, seed scale-up, filtration, concentration, chromatography, purification, etc. is highly preferred.
  • Advanced knowledge of cGMP regulations.
  • Advanced efficiency working in a Biological Safety Cabinet (BSC).
  • Demonstrated ability working with sterile tube welders, sterile tube sealers, and single-use assemblies.
  • Proven experience working with of cell expansion vessels such as T-flasks, shake flasks, cellstacks, hyperstacks.
  • Advanced 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.
  • Experience supervising, coaching, mentoring, and developing direct reports.
  • Strong background in process scale-up.
  • Outstanding written and verbal communication skills, with excellent teamwork aptitudes.
  • Demonstrated ability to plan daily activities for self and team and resolve problems in area of expertise.
  • Ability to lead and develop a team to accomplish individual and corporate goals.
  • Ability to accommodate off-shift work as required by business demand and manager request.
  • Position requires direct interaction with clients and is expected to spend 80-100% of time gowned on the Manufacturing Floor.

Physical Demands

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

Vector Manufacturing Supervisor

King of Prussia, PA, US
Apply Now >