Director of Molecular Biology, Cell and Gene Therapy Operations

Company: Center for Breakthrough Medicines
Location: West Chester
Posted on: March 20, 2023

Job Description:

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 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. The Director of Molecular will be responsible for providing senior leadership over Molecular testing services supporting Cell and Gene Therapy Programs at the Center for Breakthrough Medicines (CBM). -The Director will be a key member of the Testing Leadership team and will be responsible for leading the development of a new Molecular laboratory, transitioning and implementing GMP test methods from Analytical Development and other cross-functional groups, and CBM's clients. -The 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 Director 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. - Responsibilities

• Lead a team of highly talented scientists responsible for delivering testing for Cell and Gene Therapy Programs and new modalities
• Lead development of a new Molecular laboratory at CBM 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 Molecular 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 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
• 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 Head of Testing Operations. - - Qualifications
  • Ph.D. in relevant field with 10+ years of experience in molecular laboratory experience or M.S. degree in Molecular or related field with 15+ years of relevant experience is preferred
  • Strong background and deep subject-matter expertise in Molecular 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.
  • 10 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 - -#appcast - As an Equal Opportunity Employer, we believe in each person's potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.

Keywords: Center for Breakthrough Medicines, Wilmington , Director of Molecular Biology, Cell and Gene Therapy Operations, Healthcare , West Chester, Delaware