Director, Commercial CMC Programs

Telix Pharmaceuticals

$150K — $180K *
US-AnywhereRemote in Canada
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • BA or BS in Engineering, Biology, Chemistry, Business, or relevant field
  • 10+ years in cGMP Manufacturing, Contract Manufacturing, Business Development, or Quality
  • Experience managing cross-functional teams and external partners, including CDMOs
  • Direct experience in Sterile Injectable Filling and Lyophilization preferred
  • Experience with Secondary Packaging and complex formulations of biologics preferred
  • Ability to travel approximately 30% domestically and internationally

Responsibilities

  • Develop and implement manufacturing and operational plans for commercial assets
  • Establish and nurture relationships with contract manufacturers
  • Oversee production, quality, and development from mid-stage to commercial manufacturing
  • Manage contracts to align with company expectations while meeting budget targets
  • Collaborate with internal leaders to create manufacturing and capacity strategies
  • Coordinate communication among internal and external stakeholders
  • Lead and develop CMC Program Leads to exceed company goals

Benefits

  • Hybrid and remote work options
  • Annual performance-based bonuses
  • Equity-based incentive program
  • Generous vacation and paid wellness days
  • Support for learning and development opportunities
Full Job Description
To contribute to the achievement of the Group's commercial and strategic goals by developing manufacturing and operational plans for the Group's commercial and late-stage clinical assets in collaboration with Regional Operations leadership, Supply Chain, Program leadership, and the Director of Manufacturing Operations. As the Director, CMC Programs, you will play a critical role in overseeing a team of CMC program leads. Ensuring the effective execution of CMC strategies through the cross functional collaboration of internal and external partners. The CMC Programs team will be responsible for coordinating and delivering CMC activities in line with project requirements and company goals for Precision Medicine Diagnostics and Therapeutics programs. Setting up and solidifying global production, supply chain, logistics and distribution to support current late-phase clinical progression into commercial and ongoing commercial manufacturing of the Group's assets. Key Accountabilities: - Partner with contract manufacturers to create and maintain effective relationships. Serve as the liaison and escalation point between Telix and the External Contract Manufacturer (ECM) network - Provide oversight of the manufacturing, quality, and development of products from mid-stage clinical through ongoing commercial manufacturing. - Manage contracts to ensure delivery of company expectations while meeting budget targets - Partner with the Directors of Manufacturing Operations, Biologics, Radiochemistry, and CMC Programs to sustain ECM strategy used internally and externally - Partner with the Director of Manufacturing Operations to determine strategies for cost savings and capacity management within applicable ECMs - Partner with Program leadership, Supply Chain, and the Directors of CMC Programs to develop manufacturing and capacity strategies consistent with the current and future marketing strategies (short- and long-term) - Establish, own, and manage key ECM operating mechanisms and oversight alongside Supply Chain and Procurement - Coordinate communication between all applicable internal and external functions/organizations - Manage issues to ensure efficient and effective business resolution - Leadership, development, and performance management of the Commercial CMC Program Leads for the purpose of driving team capabilities to surpass company goals, including employing initiatives to coach employees to optimize their contribution and outputs - Lead performance business reviews with suppliers/contracting organizations - Responsible for ECM metrics for scorecard/dashboard creation and population - Commercial manufacturing budget management, including implementing continuous improvement Education and Experience: - BA or BS degree in Engineering, Biology, Chemistry, Business or other relevant field - 10+ years combined experience in cGMP Manufacturing, Contract Manufacturing, Business Development, or Quality - Experience in managing cross-functional teams, external partners, and CDMOs required - Direct experience in Sterile Injectable Filling and Lyophilization of Drug Product/Substances supporting both pre-commercial and commercial products preferred - Direct experience in Secondary Packaging of Parenteral drugs preferred - Direct experience in complex formulations of bulk drug substances and biologic drug substance manufacturing preferred - Experience managing cross-functional teams and International Contract Manufacturing Organizations - Ability to travel approximately 30% - both domestically and internationally Key Capabilities: - Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do - Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results - Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges - Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language - Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals - Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges - Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected - Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges - Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders - Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

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