Supervisor, Drug Product Manufacturing
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Supervisor, Drug Product Manufacturing

King of Prussia, PA

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Summary

The individual will be responsible for supervision of operators performing aseptic filling activities across 2-3 fill lines as well as visual inspection operations. The incumbent will be responsible for a diverse manufacturing team performing routine cGMP filling of viral vectors supporting gene and cell therapy products including Adeno-Associated Virus (AAV) and Lentivirus (LV) and provide leadership across both viral vector and cell therapy manufacturing. The individual should be a motivated self-starter eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise, have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards.

Responsibilities

  • Provide daily supervision of a team of 10-12 operators performing aseptic filling activities and visual inspection of vials. 90% of time will be spent on the manufacturing floor.
  • Work with a cross-functional team of process development, engineering, quality, etc. for the execution of cGMP-appropriate, scalable viral vector manufacturing processes.
  • Maintain aseptic gowning qualifications and train on all aspects of the aseptic filling process. Be qualified to perform process as needed.
  • Lead operational staff, develop staff capabilities, create a culture of safety, continuous improvement and training objectives, and compliance.
  • Establish key performance indicators in alignment with individual, department, and company goals; maintain and report organizational metrics.
  • Proactively identify and escalate key risks and issues to shift manager.
  • Work effectively with cross functional teams comprised of process sciences, development, facilities & engineering, tech ops, quality control, and quality assurance to ensure right-first-time execution.
  • Identify risks and propel continuous improvements in development and manufacturing processes through technological innovation and alignment with regulatory requirements for clinical and commercial vector manufacturing.
  • Ensure high levels of communication with the team, support resources, and management regarding issue identification and resolution.
  • Work closely with the production staff to troubleshoot process and equipment problems.
  • Support the team in defining and executing technical strategies.
  • Work closing with Quality Assurance and to proactively resolve issues such as deviations, CAPAs, and Change Controls.
  • Support the initial and ongoing training of staff.
  • Proactively identify opportunities for improvements in process, safety, quality, and cost.
  • Requires a willingness to work off-shift as required by business demand and manager request.

Qualifications

  • Bachelor’s degree (in biological science(s) field or related engineering) is preferred but not required
  • 3-4 years of experience in cGMP biotech manufacturing
  • 1-2 years of proven leadership experience
  • Experience with MES and integrated automation in manufacturing preferred
  • Outstanding communication skills (verbal and written)
  • Experience with some or all the following: cGMP manufacture using equipment such as automated and semi-automated aseptic fill lines, isolators, visual inspection light stations, and filter integrity testing equipment. 

Compensation: TBD

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