Manager, Drug Product Manufacturing
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Manager, 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 helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of the aseptic fill finish program. 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 Manager, Drug Product Manufacturing will be responsible for a team of supervisors and operators on a shift performing formulation and aseptic filling operations across 2-3 fill lines. 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 management oversight of product’s production flow / value stream ensuring end to end the internal supply chain delivers product timely and right-first-time, stalwart adherence to driving culture that improves operational and quality metrics.
  • Work with a cross-functional team of process development, engineering, quality, etc. for the development of cGMP-appropriate, scalable viral vector manufacturing processes.
  • Engage in proactive relationships with partners including acting as key client interface for operational interests in both tactical and strategic meetings.
  • 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 manufacturing line and site leadership team. Organize and lead ad hoc cross functional teams to develop risk mitigation plans and/or manage complex operational issues.
  • 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 technology transfer.
  • 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; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
  • Work closely with the production staff to troubleshoot process and equipment problems.
  • Work closely with senior management to initiate new production projects and assist in developing processes/techniques to meet contract objectives.
  • 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.
  • Review completed batch records. Develop training material, update curricula, close training gaps, and 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.
  • Position requires direct interaction with clients and is expected to spend 60-80% of time gowned on the Manufacturing Floor, which will involve supporting the PIP.

Qualifications

  • Bachelor’s degree (in biological science(s) field or related engineering) is preferred but not required
  • 5-8 years of experience in cGMP biotech manufacturing
  • 4-6 years of viral vector manufacturing experience preferred
  • 3-4 years of project owner/management experience preferred
  • 3-4 years of proven leadership experience
  • Experience with MES and integrated automation in manufacturing preferred
  • Outstanding communication skills (verbal and written)
  • Excellent computer and word processing skills including Microsoft Excel, PowerPoint, and Word
  • Experience with some or all the following: cGMP manufacture using equipment such as incubators, single-use bioreactors, fixed-bed bioreactors, chromatography skids, hollow-fiber and/or flat-sheet TFF, Ultracentrifugation, Filling, and other GMP manufacturing equipment. 

Compensation: TBD

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