Jobs · Engineering

Director, Manufacturing Operations

Telix Pharmaceuticals Limited · United States · 3 wk ago
RemoteRemoteEngineeringFull-time

About the Role

Telix Pharmaceuticals is seeking a leader to support the international roll-out of our approved prostate cancer imaging agent and advance our portfolio of late clinical-stage products. This role involves developing manufacturing and operational plans for commercial and late-stage clinical assets, ensuring effective leadership, execution, and delivery. You will oversee subject matter experts in Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging activities, focusing on execution to company objectives with the required level of quality.

Responsibilities

  • Partner with contract manufacturers to ensure quality, deliveries, and costs meet or exceed Telix’s expectations.
  • Provide oversight into the manufacturing, quality, and development of products from mid-stage clinical through commercial launch.
  • Partner with the Directors of CMC Programs to sustain, monitor, and improve both internal and external contract development/manufacturing organization (CDMO) strategies.
  • Determine strategies for cost savings, supply redundancy, and process improvement within the CDMO network.
  • Develop manufacturing and capacity strategies consistent with current and future marketing strategies (short and long term).
  • Manage complex technical issues to ensure efficient and effective business resolution.
  • Support quality investigations and non-conformances by providing appropriate product expertise.
  • Lead, develop, and manage a team of manufacturing engineers to drive team capabilities and surpass company goals.
  • Act as the technical lead for business reviews with suppliers/contracting organizations.
  • Oversee technical transfers and process validation at internal and external CDMOs.

Qualifications

  • BA or BS degree in Engineering, Biology, Chemistry, or other relevant field.
  • 10+ years combined experience in late-stage clinical to commercial cGMP Manufacturing, Engineering, Contract Manufacturing, and/or Quality.
  • 3+ years of previous management experience.
  • Direct experience in Sterile Injectable Filling and Lyophilization of Drug Product/Substances supporting both clinical and commercial products.
  • 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 working with International Contract Manufacturing Organizations.
  • Ability to travel approximately 30% - both domestically and internationally.

Skills

  • Commitment to excellence: Take pride in your work and consistently strive for excellence.
  • Results-oriented: Driven to achieve goals with a focus on measurable results.
  • Creativity and innovation: Willingness to think outside the box and develop unique solutions.
  • Strong communication skills: Ability to communicate effectively with colleagues and stakeholders at all levels.
  • Collaboration: Work effectively as part of a team, sharing knowledge to achieve common goals.
  • Resilience: Ability to bounce back from setbacks and persevere in the face of challenges.
  • Inclusive mindset: Understanding and appreciation for diversity, creating an inclusive environment.
  • Adaptability: Comfortable in a dynamic environment, adjusting to changing priorities.
  • Ethical behavior: Act with integrity and commitment to ethical behavior.
  • Continuous learning: Commitment to ongoing learning and professional development.

Benefits

  • Competitive salaries
  • Annual performance-based bonuses
  • Equity-based incentive program
  • Generous vacation
  • Paid wellness days
  • Support for learning and development

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Similar jobs