Summary

CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.

Job description

Responsibilities

Lead technology transfer projects across internal manufacturing sites and external partners, serving as the technical lead and ensuring successful execution of project deliverables, timelines, and transfer objectives.
Provide technical expertise and manufacturing support for process, equipment, and operational challenges, including troubleshooting, technical investigations, risk assessments, and support of commercial manufacturing campaigns.
Author, review, and maintain technical documentation including transfer plans, assessments, procedures, batch records, protocols, specifications, reports, training materials, and related compliance documentation.
Drive project execution and cross-functional collaboration by coordinating activities across Manufacturing, MS&T, Quality, Engineering, Regulatory, Supply Chain, and external partners, including CMOs and CDMOs, to achieve project milestones and business objectives.
Maintain process, equipment, and automation knowledge to support technology transfer, process performance, and continuous improvement initiatives that enhance yield, reliability, robustness, safety, and operational efficiency.
Support Regulatory and Quality compliance activities through preparation of technical documentation, support of submissions and health authority responses, and participation in deviations, change controls, CAPAs, OOS, OOE, and complaint investigations.
Manage manufacturing readiness activities, including material enrollments, BOM updates, manufacturing system changes, and the planning, execution, and support of engineering, demonstration, and validation batches to ensure successful process implementation and commercialization across a global manufacturing network.

Qualifications

Bachelor's degree in a relevant branch of Biological Science or Engineering
3-5 years' hands-on experience in process development activities
Knowledge of the regulations (FDA, EMEA, TGA) associated with GMP production
Pharmaceutical/biotech experience preferred

Requirements

Bachelor's degree in a relevant branch of Biological Science or Engineering
3-5 years' hands-on experience in process development activities
Knowledge of the regulations (FDA, EMEA, TGA) associated with GMP production
Pharmaceutical/biotech experience preferred

Company overview

CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.