Global Manufacturing Engineer
Telix Pharmaceuticals Limited
7 hours ago
Remote friendly (United States)
United States
Operations
Global Manufacturing Engineer provides technical expertise for process development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging of small molecules and biologics to meet program objectives, safety standards, regulatory expectations, and quality compliance. Serves as technical lead on internal cross-functional teams and with external CDMO partners to develop and execute clinical and commercial manufacturing.
Key Accountabilities:
- Technical lead of pharmaceutical development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging.
- Analyze production processes; identify and communicate gaps, risks, and inefficiencies; drive process improvements and risk mitigations; lead manufacturing investigations and root cause analysis.
- Manage technical collaborations with CDMOs to provide technical support and achieve key milestones.
- Author and review external manufacturing operation documents (SOPs, batch records, protocols, reports) for clinical and/or commercial products.
- Author and support submission of CMC sections in IND, NDA, BLA, and related regulatory filings.
- Ensure compliance via document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system.
Education and Experience:
- Science or engineering degree; 4+ years operational pharmaceutical experience (manufacturing operations, bioprocessing technology, validation, and engineering).
- Experience with MS Office (Excel, Word, Project).
- Experience with cross-functional teams, external partners, and CDMOs.
- Experience authoring technical documents (protocols, reports, CMC modules, filing responses).
- Strong experience in a key functional area within pharmaceutical operations.
- Experience in pharmaceutical and process development.
Key Capabilities:
- Autonomy; strong communication; creativity/innovation; inclusive mindset; commitment to excellence; results-oriented; ethical behavior; adaptability; collaboration; resilience; continuous learning.
- Travel expectation: 10–25%.
Key Accountabilities:
- Technical lead of pharmaceutical development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging.
- Analyze production processes; identify and communicate gaps, risks, and inefficiencies; drive process improvements and risk mitigations; lead manufacturing investigations and root cause analysis.
- Manage technical collaborations with CDMOs to provide technical support and achieve key milestones.
- Author and review external manufacturing operation documents (SOPs, batch records, protocols, reports) for clinical and/or commercial products.
- Author and support submission of CMC sections in IND, NDA, BLA, and related regulatory filings.
- Ensure compliance via document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system.
Education and Experience:
- Science or engineering degree; 4+ years operational pharmaceutical experience (manufacturing operations, bioprocessing technology, validation, and engineering).
- Experience with MS Office (Excel, Word, Project).
- Experience with cross-functional teams, external partners, and CDMOs.
- Experience authoring technical documents (protocols, reports, CMC modules, filing responses).
- Strong experience in a key functional area within pharmaceutical operations.
- Experience in pharmaceutical and process development.
Key Capabilities:
- Autonomy; strong communication; creativity/innovation; inclusive mindset; commitment to excellence; results-oriented; ethical behavior; adaptability; collaboration; resilience; continuous learning.
- Travel expectation: 10–25%.