09 Aug
|
Treidlia Biovet
|
Seven Hills
09 Aug
Treidlia Biovet
Seven Hills
Treidlia Biovet is an Australian vaccine manufacturer supporting animal health across the region. As we grow our Recent Product Development and process improvement pipeline, we're looking for an experienced Project Manager to bring structure, rigour and accountability to how our products move from lab bench to GMP-approved production line.
About the Role
Sitting within Regulatory Affairs and reporting to the Head of Regulatory and Government Affairs, you'll drive the operational planning, scheduling and cross-functional execution of every New Product Development (NPD) and production process change project we run. You'll partner closely with R&D;, Production, Regulatory Affairs and our Validation Lead — owning project delivery and risk frameworks from kick-off through to GMP sign-off.
This is a role for someone who thrives on scope clarity, rigorous scheduling, and holding smart, busy people accountable to a plan — without needing to be the technical expert in the room.
What You'll Be Doing
- Scope & kick-off – Lock in formulation parameters, batch sizes and process requirements with R&D;, Production, Regulatory and Validation before execution starts, securing multi-party sign-off to keep scope creep and compliance risk off the table.
- Risk management – Own the master Risk Register and facilitate cross-functional process FMEA (pFMEA) and product quality risk assessment workshops (ICH Q9), identifying failure modes and quality risks early.
- Schedule & governance – Build and maintain master Gantt charts covering procurement, pilot batches, stability testing and validation runs,
and map the tricky dependencies where lab timelines meet engineering timelines.
- GMP & tech transfer – Keep projects aligned with Change Control procedures and veterinary regulatory frameworks (APVMA, DAFF, OTGR or international equivalents), and track Equipment Qualification (IQ/OQ/PQ) and Process Validation milestones through to a seamless tech transfer.
What You'll Bring
- Bachelor's or Master's degree in Pharmaceutical Engineering, Chemical Engineering, Process Engineering or a related bioprocess discipline.
- 3–5+ years' project management or coordination experience in a GMP-regulated environment — veterinary medicines, pharmaceuticals or biologics experience highly regarded.
- A track record managing both NPD scale-ups and manufacturing process changes.
- Hands-on experience facilitating FMEA / ICH Q9 risk workshops.
- The organisational discipline to build a Gantt chart that actually gets followed, and the communication skills to chase deliverables from busy lab, operations and quality teams without burning bridges.
- Confidence with MS Project, Smartsheet or equivalent enterprise scheduling tools.
Why Join Us
You'll play a genuinely cross-functional role at the intersection of science, engineering and compliance — with real ownership over how our products get from concept to market. If you like bringing order to complex, multi-stakeholder projects and want your work to directly support animal health outcomes, we'd love to hear from you.
Apply now with your resume and a short cover note on your GMP project management experience.
📌 Project Manager – NPD & Process Development (Seven Hills)
🏢 Treidlia Biovet
📍 Seven Hills