Head of Testing Operations, Cell and Gene Therapy Testing

King of Prussia

Summary

The Head of Testing Operations will be responsible for providing senior leadership over the GMP Testing laboratories supporting Advanced Therapy Testing at Center for Breakthrough Medicines (CBM).The Head of Testing will be a key member of the Testing Leadership team and will be responsible for leading the development and deployment of new GMP laboratories and future expansions.The Head of Testing will be responsible for managing a large team of Cell and Gene Therapy departments that will be directly responsible for delivering results to our customers for complex characterization and product release methods, implementing new technologies and innovation and executing CBM’s strategy to serve our clients, bringing cell and gene therapies from bench to bedside.

Responsibilities

  • Lead a team of high performing team of technical departments responsible for delivering testing for Cell and Gene Therapy Programs, with a focus on the science and execution for CBM’s clients
  • Lead execution of CBM’s business strategy to grow the testing departments deliver on cell and gene therapy programs supporting GMP work.
  • Provides technical and scientific leadership to the departments responsible for GMP Testing supporting Cell and Gene Therapy Programs
  • Responsible for managing a total of over 200 staff 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.

·Maintain Operational execution of the department to CBM expectations through regular business reviews and other performance management activities.

  • Develops talent strategies and implements hiring, and broader talent issues and provides people-related decisions for a department/multiple teams within Testing and Analytical Services that cultivates innovative culture.
  • Actively lead the strategic direction and goals of the department
  • Develop and Manage department budgets and management of P&L
  • Build and foster relationships across the technical operations groups, Analytical Development Departments, contributing to projects and peer review when required
  • Responsible for ensuring quality, consistency and best practice within reporting line
  • Accountable for scientific development and mentoring of scientists within reporting line
  • Fostering a culture of scientific rigor and continuous improvement in line with the Innovation Performance and Trust strategy at The Center for Breakthrough Medicines
  • Ensure compliance with The Center for Breakthrough Medicines values and policies

·Evaluate risks and opportunities with Sr. 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.

  • Continuously reach out to academia, conferences, literature to stay ahead of developments in the space of Cell and Gene Therapy

·Monitor the effective implementation of appropriate EHS and Biosafety procedures and provide for their updating in line with SOPs.

·Where required, and in partnership with QA/Regulatory Affairs, meet with relevant Regulatory Bodies to resolve any compliance issues or help with any new business requirements that potentially impact the accreditation or compliance status.

·Represent the Company to customers, visitors, community organizations, local/state and governmental authorities, unions, industry associations and regulatory agencies.

·Perform all other related duties as assigned by the SVP of Testing & Analytical Services.

Education & Experience

·Advanced technical degree in Virology / Molecular / Biochemistry or related field, with 15+ years of relevant experience in Managing large teams.

·Experience managing a large team of full-time scientists, supporting multiple projects and fostering a culture of innovation, teamwork, performance and trust, with 8 – 10 years (minimally) of People Management experience is required.

  • 10 years of biotechnology experience or relative industry experience is required, with experience in Gene Therapy preferred.
  • Operational experience in development of processes with focus on metrics (quality, technical and business) to drive improvements and scalability
  • Experience with budget and schedule management and deployment of business strategies
  • Strong management/leadership skills and demonstrated ability to lead large teamsto 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

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