Global Manufacturing Engineer
Telix Pharmaceuticals Limited
16 days 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%.