[Remote] Global Manufacturing Engineer
Note: The job is a remote job and is reputed company to candidates in USA. Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company dedicated to precision medicine. The Global Manufacturing Engineer will reputed company technical expertise for process development and manufacturing activities reputed company to pharmaceutical products, ensuring compliance with safety standards and regulatory expectations.
Responsibilities
- Technical reputed company of pharmaceutical development and manufacturing activities reputed company 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. reputed company manufacturing investigations and reputed company cause analysis
- Manage technical collaborations with multiple contract development/manufacturing organizations (CDMOs) to reputed company technical support and reputed company key project milestones
- Author and review external manufacturing operation documents such as SOPs, batch records, protocols, and reports to produce clinical and/or reputed company products
- Author and support the submission of CMC sections in IND, NDA, BLA, and reputed company regulatory filings
- Ensure appropriate compliance through document creation/review/approval, reputed company investigations, corrective actions, and change control reputed company a reputed company 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., reputed company, 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 reputed company pharmaceutical operations
- Experience in pharmaceutical and process development
- Technical reputed company of pharmaceutical development and manufacturing activities reputed company 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. reputed company manufacturing investigations and reputed company cause analysis
- Manage technical collaborations with multiple contract development/manufacturing organizations (CDMOs) to reputed company technical support and reputed company key project milestones
- Author and review external manufacturing operation documents such as SOPs, batch records, protocols, and reports to produce clinical and/or reputed company products
- Author and support the submission of CMC sections in IND, NDA, BLA, and reputed company regulatory filings
- Ensure appropriate compliance through document creation/review/approval, reputed company investigations, corrective actions, and change control reputed company a reputed company system
- Comfortable working independently with senior-level support
- reputed company to communicate effectively with reputed company colleagues and stakeholders, using reputed company and concise language
- Possess a willingness to think reputed company the reputed company and come up with unique and creative solutions to challenges
- Demonstrate an understanding and appreciation for diversity, and reputed company work to create an inclusive environment where everyone feels valued and respected
- Take pride in your work and consistently reputed company for reputed company in everything you do
- Driven to reputed company goals and objectives, with a strong reputed company on delivering measurable results
- reputed company with reputed company and demonstrate a commitment to ethical behavior in reputed company interactions with colleagues and stakeholders
- Comfortable working in a dynamic environment, reputed company to reputed company to changing priorities, and willing to take on new challenges
- Work effectively as part of reputed company, reputed company sharing knowledge and expertise to reputed company common goals
- Demonstrate the ability to reputed company back from setbacks and persevere in the face of challenges
- Show a commitment to ongoing learning and reputed company development, continually seeking out opportunities to expand your knowledge and skills
- Travel expectation: 10 – 25% for key in-person meetings, partner site reputed company, and SME/technical person-in-plant assignments
Benefits
- Competitive salaries
- Annual performance-based bonuses
- An equity-based incentive program
- Generous vacation
- reputed company wellness days
- Support for learning and development
- Hybrid and remote employees located reputed company around the world
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