Associate Director Manufacturing Support Services, Viral Vector
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Associate Director Manufacturing Support Services, Viral Vector

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

Center for Breakthrough Medicines is seeking a Director of Operations with proven technical skills to lead a client-oriented team and focus on delivering operational excellence within the organization and industry.

The Head of Manufacturing Support Services Supervisor will be responsible for helping to drive the on-time-delivery of start-up activities and establish a Support Services Department. The incumbent will lead, guide, and train a diverse team of leaders in the support of the manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines. Support Services include Buffer, Media, and Solution preparation, Component and Parts preparation and sterilization, Inventory Control and Material Movement, Manufacturing Coordination, and Cleaning Services. This individual will work closely with the Head of Upstream, Downstream, and Drug Product Manufacturing for the Vector Asset at the CBM.

We’re looking for an individual who is a motivated self-starter and eager to contribute to building manufacturing operations 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.
    • Lead, motivate, and develop personnel by promoting the CBM culture:
    • Be Committed
    • Ignite Innovation
    • Respect All
    • Embrace Customers
    • Empower
    • All In (Diversity, Inclusion, and Equality)
  • 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.
  • Work closely with manufacturing personnel to troubleshoot process and equipment problems.
  • Build a Support Services Organization for internal and external customers that includes Material Movement and Inventory Control, Buffer and Solution Preparation, Component Preparation and Sterilization, and Cleaning Services.
  • Work closely with stakeholders in the resolution of manufacturing deviations/non-conformances and troubleshooting of 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.
  • Complete same-day review of completed batch records, logbooks, and other supporting documentation.
  • Establish business processes that ensure start, completion, and delivery in full of program objectives.
  • Oversees training goals for the department to develop a high functioning team.
  • Work effectively with cross functional teams using Operational Excellence tool and standard work.
  • Provides timely technical input to support ongoing operations.
  • Proactively identify opportunities for improvements in process, safety, quality, and cost.
  • Escalate key risks and issues to manufacturing line and site leadership team.
  • Is comfortable in a start up Environment.
  • Ensure materials are ordered, procured, and inventory is delivered to manufacturing areas and consumes and issued when used.
  • Establish an inventory management business process within the platform to ensure continuous operations and just in time delivery.
  • Works with internal and external resources to establish a cleaning program and services at CBM.
  • Opportunity to expand the department to support operations outside of vector. 

Qualifications

  • High school diploma is required, but a degree in a related field is preferred.
  • 10+ years of experience in cGMP manufacturing, clinical or commercial. CDMO experienced preferred.
  • A minimum of 5+ years of leadership experience is preferred.
  • Advanced experience working with Solution preparation equipment, part and component prep, and sterilizing autoclaves, is highly preferred.
  • Oversight of support services and cleaning services preferred.
  • Advanced knowledge of cGMP regulations is required.
  • Demonstrated ability working with a cross functional teams is required.
  • 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.
  • 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 regulatory agencies as needed.
  • Must have the ability to gown in a clean room environment and apply required PPE for some period to perform audits, GEMBA walks, tours.
  • This is not a remote position, but will allow limited allowances for Work From Home opportunities.

Compensation: TBD

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