[Remote] Global Manufacturing Engineer

Note: The job is a remote job and is open to candidates in USA. Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company dedicated to precision medicine. The Global Manufacturing Engineer will provide technical expertise for process development and manufacturing activities related to pharmaceutical products, ensuring compliance with safety standards and regulatory expectations.ResponsibilitiesTechnical lead of pharmaceutical development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging of small molecules and biologicsAnalyze production processes and report results. Identify and communicate gaps, risks, and inefficiencies. Drive implementation of process improvements and risk mitigations. Lead manufacturing investigations and root cause analysisManage technical collaborations with multiple contract development/manufacturing organizations (CDMOs) to provide technical support and achieve key project milestonesAuthor and review external manufacturing operation documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial productsAuthor and support the submission of CMC sections in IND, NDA, BLA, and related regulatory filingsEnsure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality systemSkillsScience or engineering degree with 4+ years of relevant operational pharmaceutical experience across a breadth of functions including but not limited to, manufacturing operations, bioprocessing technology, validation, and engineeringExperience in MS Office suite applications (e.g., Excel, Word, Project)Experience working with cross-functional teams, external partners and CDMOsExperience in authoring challenging technical documents, including but not limited to, protocols, reports, CMC modules, and filing responseStrong experience in a key functional area within pharmaceutical operationsExperience in pharmaceutical and process developmentTechnical lead of pharmaceutical development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging of small molecules and biologicsAnalyze production processes and report results. Identify and communicate gaps, risks, and inefficiencies. Drive implementation of process improvements and risk mitigations. Lead manufacturing investigations and root cause analysisManage technical collaborations with multiple contract development/manufacturing organizations (CDMOs) to provide technical support and achieve key project milestonesAuthor and review external manufacturing operation documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial productsAuthor and support the submission of CMC sections in IND, NDA, BLA, and related regulatory filingsEnsure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality systemComfortable working independently with senior-level supportAble to communicate effectively with internal and external colleagues and stakeholders, using clear and concise languagePossess a willingness to think outside the box and come up with unique and creative solutions to challengesDemonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respectedTake pride in your work and consistently strive for excellence in everything you doDriven to achieve goals and objectives, with a strong focus on delivering measurable resultsAct with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholdersComfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challengesWork effectively as part of a team, actively sharing knowledge and expertise to achieve common goalsDemonstrate the ability to bounce back from setbacks and persevere in the face of challengesShow a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skillsTravel expectation: 10 – 25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignmentsBenefitsCompetitive salariesAnnual performance-based bonusesAn equity-based incentive programGenerous vacationPaid wellness daysSupport for learning and developmentHybrid and remote employees located all around the worldCompany OverviewTelix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals to address significant unmet medical need in oncology and rare diseases. It was founded in 2015, and is headquartered in Melbourne, Victoria, AUS, with a workforce of 1001-5000 employees. Its website is http://www.telixpharma.com.