Senior Process Engineer
The Opportunity:
Building on the success of our recent US approval for HEMGENIX (etranacogene dezaparvovec-drlb), the world's first gene therapy for hemophilia B, you will join a lean but growing team committed to bringing innovative gene therapies to patients.
As a Sr. Process Engineer, you will develop and maintain expert knowledge of AAV viral vector processes and facilities. You will provide a vital link between CSL and contract manufacturing partners, driving improvements in process yield, robustness, and reliability. Working in a highly matrixed team environment you will also play a pivotal role in technology transfer as part of capacity expansion projects.
The Role:
- Championing transformation of process engineering, manufacturing technologies & innovation at CSL
- Actively contribute and lead tech transfer of gene therapy products from/to another site including CMOs
- Support of site-specific root cause analysis in the manufacturing process and process technology as well as resolving issues/challenges in manufacturing
- Lead and manage process improvement with respect to yield, quality and time
- Lead and manage local and global capacity expansion projects to ensure a reliable supply for our patients
- Actively and self-reliantly, take decisions within capital projects and drive progress. Support good collaboration within the projects and regularly report the status
- Providing process engineering support to front end design in capital projects for gene therapy products
- Establishing global design standards for upstream and downstream manufacturing in collaboration with internal stakeholders
- Scouting, evaluating, and implementing new technologies for gene therapy in collaboration with R&D
- Actively contributing to the business success through continuous improvement and innovation initiatives
- Expected to take a leadership role in project teams and be an active participant (including decision-taking) in intercompany, cross-value stream projects
- Being a role model for expected behaviors and practices in accordance with the CSL values and guidelines for health, safety, and environment
Your skills and experience:
- University degree in chemical or process engineering, preferably with PhD
- >10 years of work experience in the bio-pharmaceutical industry and with specific skills in gene therapy processing
- GMP experience and awareness of state-of-the-art industry practices and trends in the field
- Proven track record in managing projects, programs and manufacturing processes in a highly regulated environment as well as managing performance and delivering business value
- Exceptional interpersonal and collaboration skills
- Innovative thinker with strong business acumen who drives results
- Ability to manage competing priorities and agendas
- Excellent stakeholder focus and collaborative mindset, ability to inspire others and at all times exemplifying CSL values
- Attentive communication skills, understanding your counterpart, strong ability to build-up trustful and forward-thinking business relationships as well as keeping your stakeholders informed, using influencing & negotiation skills if appropriate
- Excellent written and spoken English language skills