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Associate Director/Director of In-Process Analytics and Characterization

King of Prussia, PA, US
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Summary

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 concept 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.

The Associate Director/Director of In-Process Analytics will be responsible for providing leadership and management over a team of analytical scientists, in support of cell and gene therapy Process Development at the Center for Breakthrough Medicines. The AD/Director will be a key member of the Process Development leadership team and will be responsible for interfacing with Analytical Development, managing method transfer and performance to Process Development, and execution of methods. The AD/Director will be responsible for building and managing a team of cell and gene therapy scientists supporting in-process and characterization methods. A key focus of this position is to ensure fit-for-purpose methods and performance to support the high demand and rapid analytics required for Process Development as it relates to titer and impurity measurements, as well as developing a strong relationship with Analytical Development to drive continuous improvement and issue resolution.

Responsibilities

  • Lead a team of highly talented scientists and associates responsible for method transfer, execution, review, and reporting for cell and gene therapy products.
  • Provides technical and scientific leadership to the team responsible for in-process analytics and characterization methods including flow cytometry, plate-based assays (ie, ELISA and infectious titer), PCR-based assays (ie qPCR, dPCR, ddPCR), and other common analytics.
  • Transfer, bridge, monitor, and optimize analytical methods and support all related documentation (test methods, SOPs, protocols, reports)
  • Interface with key stakeholders including Process Development leads, Program Leadership, Analytical Development, and clients to ensure efficient and effective communication and knowledge exchange occurs as well as the establishment of necessary processes, procedures, and systems
  • Responsible for managing the professional development of direct reports, with plans for future expansion.
  • Execute on the cell and gene therapy strategy, in alignment with all CBM operations and support functions
  • Establish and monitor performance against established KPIs, internal metrics and trends to ensure the department performance against Safety, Compliance, Technical Trending and Delivery.
  • Accountable for scientific development and mentoring of scientists within reporting line
  • Fostering a culture of scientific rigor and continuous improvement
  • Ensure compliance with The Center for Breakthrough Medicines values and policies
  • Evaluate risks and opportunities with Management and drive strategic outcomes for the business.
  • Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems. Conducts employee performance appraisals in a timely and objective manner. Monitors the growth and career development of direct reports.
  • Ensure quality and assists Quality Assurance in maintaining all technical and regulatory requirements.
  • Monitor the effective implementation of appropriate EHS and Biosafety procedures and provide for their updating in line with SOPs.
  • Represent the Company to customers, visitors, community organizations, local/state and governmental authorities, unions, industry associations and regulatory agencies.

Qualifications

  • Ph.D. in relevant field with 8+ years of cell biology laboratory experience or M.S. degree with 10+ years of relevant experience is preferred
  • Strong background and subject-matter expertise in process analytics and characterization required.
  • Experience managing a large team of full-time scientists, supporting multiple projects, and fostering a culture of innovation, teamwork, performance, and trust, with >2 years of people management experience is required.
  • >5 years of biotechnology or relevant industry experience is required.
  • Demonstrated experience transferring, bridging, training staff, and monitoring method performance.
  • Experience with cell-based functional bioassay techniques, including advanced cell culture techniques, plate-based spectrophotometer assays, ELISA, flow cytometry, RT-PCR, reporter cell lines, imaging techniques, biostatistical analysis tools.
  • Strong management/leadership skills and demonstrated ability to lead a group of scientists to deliver on objectives in defined timelines is required.
  • Independent, self-motivated, and innovative and the ability to excel in a goal-oriented, multifaceted and fast-moving team environment are required.
  • Outstanding communication, organizational and leadership skills, with a successful track record of collaborating with cross-functional scientific teams is required.
  • Capable of multi-tasking but with attention to detail, working on multiple projects, while delivering on objectives and budget

Associate Director/Director of In-Process Analytics and Characterization

King of Prussia, PA, US
Apply Now >