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.
Responsibilities
- Technical lead of pharmaceutical development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging of small molecules and biologics
- Analyze 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 analysis
- Manage technical collaborations with multiple contract development/manufacturing organizations (CDMOs) to provide technical support and achieve key project milestones
- Author and review external manufacturing operation documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial products
- Author and support the submission of CMC sections in IND, NDA, BLA, and related regulatory filings
- Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system
Skills
- Science 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 engineering
- Experience in MS Office suite applications (e.g., Excel, Word, Project)
- Experience working with cross-functional teams, external partners and CDMOs
- Experience in authoring challenging technical documents, including but not limited to, protocols, reports, CMC modules, and filing response
- Strong experience in a key functional area within pharmaceutical operations
- Experience in pharmaceutical and process development
- Technical lead of pharmaceutical development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging of small molecules and biologics
- Analyze 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 analysis
- Manage technical collaborations with multiple contract development/manufacturing organizations (CDMOs) to provide technical support and achieve key project milestones
- Author and review external manufacturing operation documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial products
- Author and support the submission of CMC sections in IND, NDA, BLA, and related regulatory filings
- Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system
- Comfortable working independently with senior-level support
- Able to communicate effectively with internal and external colleagues and stakeholders, using clear and concise language
- Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
- Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- Take pride in your work and consistently strive for excellence in everything you do
- Driven to achieve goals and objectives, with a strong focus on delivering measurable results
- Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
- Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
- Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
- Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
- Travel expectation: 10 – 25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignments
Benefits
- Competitive salaries
- Annual performance-based bonuses
- An equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote employees located all around the world
Company Overview
Telix 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.