CMC Program Lead in Canada Creek, Nova Scotia at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a CMC Program Lead in Canada.

This role offers a high-impact leadership opportunity within the development of innovative radiopharmaceutical therapies and diagnostics aimed at addressing critical unmet needs in oncology and rare diseases. You will lead end-to-end CMC strategy execution for complex biologic and antibody-conjugate programs, ensuring alignment across preclinical and early clinical development stages. Acting as the central integrator across multiple scientific and operational functions, you will coordinate internal teams and external partners to deliver robust, compliant, and timely CMC outcomes. The position requires strong scientific expertise combined with strategic program leadership in a highly regulated and fast-evolving environment. You will play a key role in driving Quality by Design principles and ensuring Stage-Gate readiness across development milestones. This is a highly collaborative role with significant visibility and influence across global program teams.

• Develop, own, and execute integrated CMC strategies for antibody-based radiopharmaceutical programs from preclinical stages through Phase 1 clinical supply
• Apply Quality by Design (QbD) principles to define target product profiles, critical quality attributes, process parameters, and control strategies
• Act as the single point of accountability for all CMC-related matters within assigned programs and lead the CMC sub-team across functions
• Coordinate cross-functional activities across Drug Substance, Drug Product, Analytical Development, QA/QC, Supply Chain, and Regulatory teams
• Maintain and manage integrated CMC plans, risk registers, decision logs, dashboards, and Stage-Gate readiness documentation
• Oversee CMC timelines, budgets, deliverables, and ensure alignment with overall program objectives and governance structures
• Identify, assess, and mitigate CMC risks while ensuring proactive escalation and resolution of critical issues
• Manage relationships with internal manufacturing sites and external CDMOs/CMOs, ensuring compliance with technical and contractual requirements
• Support technology transfer activities and ensure smooth transition between development stages
• Provide regular updates to senior leadership on program status, risks, and resource needs

• Bachelor’s degree in Science, Engineering, Mathematics, or a related discipline
• 10+ years of experience in pharmaceutical, biotech, or radiopharmaceutical CMC development
• At least 5+ years of experience in CMC program or project management within complex matrix environments
• Strong background in biologics (e.g., monoclonal antibodies, bioconjugates) and/or radiopharmaceutical development
• Deep understanding of drug development lifecycle, including upstream/downstream processing, radiochemistry, and fill-finish operations
• Knowledge of global regulatory frameworks (FDA, IND, NDA/BLA) and ICH guidelines (Q8–Q12)
• Proven ability to manage multi-site, cross-functional programs and external partnerships (CDMOs/CMOs)
• Strong project management, organizational, and decision-making skills in fast-paced environments
• Excellent communication, stakeholder management, and leadership capabilities
• Ability to operate independently with strong initiative, adaptability, and continuous improvement mindset
• Willingness to travel occasionally to support global collaborations

• Competitive compensation package including base salary, annual performance bonus, and equity-based incentives
• Generous vacation allowance and paid wellness days
• Hybrid and remote work flexibility within a global organization
• Strong focus on learning, development, and career growth opportunities
• Opportunity to contribute to impactful programs in precision medicine and oncology innovation
• Collaborative, mission-driven, and international work environment
• Inclusive workplace culture with a strong emphasis on diversity and ethical practices