The Director of Analytical GMP Operations will be responsible for providing senior leadership over Analytical Chemistry testing services (e.g HPLC, CE, ELISA, UV Nano, Gels, etc) 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 transition of developed methods to GMP ready from Analytical Development, cross-functional groups and/or CBM 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.
- Lead a team of highly talented scientists responsible for delivering testing for Cell and Gene Therapy Programs and new modalities
- Provides technical and scientific leadership to the team responsible for validation and GMP Testing of Analytical 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.
- 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 Analytical methodologies
- 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