Manufacturing Operations Director
19 hours ago
Vancouver BC, Greater Vancouver Regional District, BC; British Columbia, Canada
Telix Pharmaceuticals Limited
Full-time
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Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
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 s of CMC Programs . through the delivery of process development and improvement required for contract and regulatory compliance as well as commercial viability ; by ensuring adequate global production, supply chain, logistics and distribution planning to support current clinical development and commercial development of the Group’s assets . This role oversees subject matter experts in Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging activities with focus on execution to company objectives with the level of quality needed per stage.
Partner with contract manufacturers to ensure quality, deliveries and costs meet or exceedTelix's expectations.
Provide oversightintothe manufacturing, quality, and development of products frommid-stage clinical through commercial launch.
Partner withthe Directors of CMC Programs to sustain,monitor, and improve both internal and external contract development/manufacturing organization (CDMO)strategies.
Partner with the Directors of CMC Programs to determine strategies for cost savings,supply redundancy, and process improvementwithinCDMO network.
Partner with Programleadership, Supply Chain, and the Directors of CMC Programsto develop manufacturing and capacity strategies consistent with the current and future marketing strategies (short and long term).
Managecomplex technicalissues to ensure efficient and effective business resolution.
Support quality investigations and non-conformances by providingappropriate productexpertise.
Leadership, development, and performance management of the team ofmanufacturing engineers for the purpose of driving team capabilities to surpass company goals, including employing initiatives to coach employees tooptimizetheir contribution and outputs.
Oversee technical transfers and process validation at internal and externalCDMOs.
BA or BS degree in Engineering, Biology, Chemistry, orotherrelevant field
~10+ years combined experience inlate-stage clinical to commercialcGMP Manufacturing, Engineering, Contract Manufacturing,and/orQuality
~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
~ Experience working with International Contract Manufacturing Organizations
~ Ability to travel approximately 30%
- both domestically and internationally Possess a willingness to think outside the box and come up with unique and creative solutions to challenges Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. 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. 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. #
- both domestically and internationally Possess a willingness to think outside the box and come up with unique and creative solutions to challenges Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. 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. 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. #