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New\ Opening SR Director FabryTHINK ABOUT IT,VERY Quickly ! Position: Senior Director, Fabry CMC Lead Manager: Executive Vice President, Tech Ops Department: Tech Ops Location: Brisbane, CA JOB SUMMARY: The Sr Director is accountable for and leads the Fabry CMC team and coordinates and manages all activities in Technical Operations related to the Fabry program, provides CMC stewardship of the program and represents Technical operations on the cross-company program core team. This role reports currently to the EVP Technical Operations. Fabry is our lead wholly owned program about to enter late stage activities. The CMC Program lead will apply practical project management skills, business management understanding, matrix leadership skills, and biopharmaceutical knowledge to deliver timely and successful project completion through BLA submission and eventual approval. This role may over time manage other projects from R&D development through pre-clinical, clinical, BLA filing, commercial launch and Life Cycle Management. This incumbent will be a key member of the CMC Project Management and Technical Operation teams, working collaboratively to ensure that all CMC-related activities are in alignment with program business objectives. This person will interact with, and influence, senior internal and external stakeholders. ESSENTIAL FUNCTIONS: CMC Project Management Develop and maintain the integrated CMC project plans to identify/communicate interdependencies as well as critical path activities. Drive cross-functional communication and timely and effective decision making, utilizing meeting management best practices. Prepare and present CMC project status reports and metrics to cross-functional Teams and Management. Facilitate relevant CMC scenario planning particularly around key program inflexion points, gathering stakeholder input, evaluating options and determining the team's recommendations including timing & impact (budget, FTE, or other) for initiating at-risk activities. Lead program CMC deliverables tracking and ensuring the team is proactively identifying issues and assist with driving to the right resolutions. Coordinate the identification of strategic and executional risks, assisting to ensure the appropriate contingency plans are in place. Support managing CMC related financial budget activities in accordance with program timeline and budget. Leading establishing and improving business processes and tools for CMC program leadership. Conduct appropriate lessons learned activities to continually improve our business processes and actively share best practices approaches across programs. CMC Matrix Leadership Lead the program CMC activities by working effectively and collaboratively with external vendors and with all internal CMC stakeholders (CMC Regulatory, internal and external Manufacturing, QA, QC, Supply Chain, Clinical Operations, Process Development, Analytical Development, Formulation development, R&D) at the different stages of development. Foster a positive team culture of ownership and accountability including continuous evaluation, recognition, and process improvement. Align the organization on the program priorities and applying appropriate level of detail and follow up. Represent the CMC function on any external due diligence activities related to the program and with any external program partnerships, together with alliance management. CMC Stewardship Provide CMC input on major GMP investigations, product specifications stability plans Assist with proposed program changes ensuring they have the appropriate change rationale, taking into consideration the impact to the program development strategy, program timeline, program budget, resources, and overall program risk. Provide CMC input into comparability strategy as relevant. Provide input on the regulatory strategy, review of product-related regulatory submissions, author CMC content as appropriate and support product-specific questions. Support the product control strategy, including risk assessments, process characterization strategy, process validation (PPQ) strategy and the cleaning validation plan. Establish and maintain product knowledge expertise, ensuring critical processing knowledge is captured and shared appropriately. CMC Lead on Program Core Team As the single CMC representative, accountable to program core team for all CMC aspects (strategic and operational) for assigned programs. Define all CMC activities required for implementation of the product development plan and ensure alignment with business objectives. Ensure alignment of CMC operational plans with overall program plans and facilitate the timely execution of drug development project plans through proactive management of operational interfaces between the CMC teams and other functions. Contribute to, challenge and support the overall Product Development Plan (outside of CMC). Provide input on all Program Core Team deliverables including program goals, program plans and scenario planning program risk management and program communication plans. EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: Candidate must possess: Minimum of a bachelor’s in life science or engineering field; a MS or PhD is preferred. Minimum of 18 years related experience in the biotechnology or pharma industry, ideally for gene-based and cell-based therapies. Minimum of 10 years’ experience in leading a CMC development. Advanced knowledge of drug development with direct experience with gene-based and cell-based therapies preferred. Experience with late-stage development and product licensure is highly desired. Leadership and management skills to grow and manage a Program Development. Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders. Strong background in FDA, ISO, EMA, GMP and ICH requirements Proven experience with regulatory submissions (IND, BLA, MMA, etc.), ideally for products which were ultimately approved for commercial distribution. Strong planning and tracking skills, able to see big picture, well-organized, focused on results, capable of managing multiple projects, excellent time management with respect to priorities and self-management Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills. OTHER REQUIREMENTS: Excellent interpersonal skills Outstanding organizational skills Excellent written and oral communication skills Strong focus on customer service Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables Self-reliant, a good problem solver and results-oriented Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives. |
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