Objective

Essential Functions

• Serve as the senior CMC program leader, partnering with technical subject matter experts to translate development, manufacturing, and regulatory objectives into integrated execution plans and measurable deliverables.
• Develop a deep understanding of Perspective's radiopharmaceutical development programs, including Pb-212 manufacturing, analytical methods, process development, regulatory commitments, and technology transfer activities, and use that knowledge to identify opportunities to accelerate execution and reduce program risk.
• Develop and maintain integrated execution plans across CMC, manufacturing, Quality, Regulatory, and Supply Chain functions, including critical path timelines, milestones, resource requirements, dependencies, and decision points.
• Drive strategic and operational planning for CMC activities spanning early development through commercialization, including process development, manufacturing scale-up, technology transfer, validation readiness, and supply planning.
• Coordinate cross-functional CMC deliverables required to support regulatory submissions, manufacturing readiness, and program milestones, ensuring alignment across development, manufacturing, quality, regulatory, and supply chain functions.
• Lead cross-functional planning, execution tracking, and issue resolution for technology transfer activities, partnering with Development, Manufacturing, Quality, Regulatory, Supply Chain, and external manufacturing partners to ensure successful transfer of processes and methods from development through clinical and commercial manufacturing.
• Lead integrated CMC risk management: proactively identify, assess, and facilitate cross-functional review of technical, operational, manufacturing, quality, and supply chain risks; develop mitigation plans; and escalate critical path issues to CMC leadership as appropriate.
• Partner with Regulatory Affairs, Quality, Manufacturing, and Technical Operations to support CMC regulatory strategy and submission activities, including contributions to INDs, IMPDs, NDA/BLA submissions, and related health authority interactions.
• Partner with Supply Chain and Clinical Operations to ensure uninterrupted clinical supply through coordinated planning of calibration standards, clinical trial materials (CTM), and clinical comparator supply.
• Schedule and lead recurring CMC team meetings and working sessions; maintain project plans, action registers, risk logs, and status updates to support effective execution and decision-making.
• Support the continued evolution of program management practices, tools, and processes within the CMC organization.

Qualifications

Education / Experience

• Advanced degree (M.S., Ph.D., or Pharm.D.) in pharmaceutical sciences, chemistry, chemical engineering, biochemistry, or a related life sciences discipline; equivalent industry experience considered.
• Strong program and project management experience in the pharmaceutical industry working with cross functional teams.
• Minimum 10 years of experience in pharmaceutical or biotechnology, radiopharmaceutical, manufacturing, technical operations, or CMC development roles, including significant experience leading complex cross-functional initiatives.
• Experience working closely with Manufacturing, Technical Operations, Quality, Supply Chain, and Regulatory functions to deliver key CMC milestones.
• Experience supporting radiopharmaceutical, biologics, cell therapy, gene therapy, sterile injectable, or similarly complex development and manufacturing programs preferred.
• Experience contributing to regulatory submissions and CMC documentation, with ability to effectively translate regulatory requirements into executable development and manufacturing plans

• Strong technical understanding of pharmaceutical or radiopharmaceutical CMC development, including drug substance, drug product, analytical development, process development, manufacturing, and technology transfer activities.
• Working knowledge of GMP manufacturing requirements and regulatory expectations for CMC: FDA, EMA, and ICH guidelines; familiarity with CTD Module 3 structure and content requirements.
• Demonstrated ability to rapidly understand highly technical development and manufacturing challenges and convert them into practical execution plans.
• Ability to effectively engage scientists, engineers, manufacturing personnel, quality professionals, and regulatory stakeholders to drive accountability and deliver results.
• Track record of successfully executing technology transfer programs to contract manufacturing organizations (CMOs / CDMOs), including development of transfer protocols, gap assessments, and milestone tracking.
• Strong quantitative and analytical skills; demonstrated ability to develop and maintain critical path analyses, scenario planning models, risk registers, and CMC program dashboards / metrics.
• Familiarity with program management tools: MS Project, Excel, SharePoint o0r alike, PowerPoint, and related project tracking platforms.
• Ability to facilitate meetings and discussions effectively both in-person and virtually across global time zones.
• Ability to travel up to 30%.

Work Environment

• May be required to sit or stand for long periods of 8+ hours a day while performing duties. 
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.