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.
The Senior Director of Virology will be responsible for providing senior leadership over Virology testing services supporting Cell and Gene Therapy Programs at CBM. The Sr. Director will be a key member of the Testing Leadership team and will be responsible for leading the development of a new Virology laboratory, transitioning, and implementing GMP test methods from Analytical Development and other cross-functional groups, and CBM’s clients. The Sr. Director will be responsible for managing a large team of Cell and Gene Therapy scientists that will be directly responsible for delivering results to our customers for complex characterization and product release methods. The role will also be responsible for driving the strategy and execution of new analytical technologies and techniques to serve our clients, bringing cell and gene therapies from bench to bedside.
- Lead a team of highly talented scientists responsible for delivering testing for Cell and Gene Therapy Programs, with a focus on AAV
- Lead development of a new Virology laboratory at TDL for cell and gene therapy programs that will be supporting GMP work.
- Provides technical and scientific leadership to the team responsible for validation and GMP Testing of Virology assays supporting Cell and Gene Therapy Programs
- Responsible for managing a total of 30 – 40 Scientists with plans for future expansion.
- Execute on the cell and gene therapy strategy, in alignment with all TDL 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 The Discovery Labs 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
- 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 (IPT) 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 VP of Testing and Analytical Services.
- M.D. or Ph.D. in relevant field with a minimum of 10 years of experience in virology / molecular laboratory experience or M.S. degree in virology or related field with a minimum of 15 years of relevant experience is preferred
- Strong background and deep subject-matter expertise in virus biology
- Experience managing a large team of full-time scientists, including PhD level scientists, supporting multiple projects, and fostering a culture of innovation, teamwork, performance, and trust, with 5 years (minimally) of People Management experience is required.
- 12+ years of biotechnology experience or relative industry experience is required, with experience in Gene Therapy preferred.
- Demonstrated Experience transferring, qualifying, and validating to a GMP lab setting (cGMP experience is required).
- 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
Reports to: Vice President Testing and Analytical Services