Manager, Process Engineering (DSP)
Thermo Fisher Scientific
- Brisbane, QLD
- Permanent
- Full-time
- Ensure DSP PE team delivers on all performance metrics for the site and network.
- Develop and mentor Process and Support Engineers.
- Coordinate technology transfer, facility fit and implementation of NPIs along with PPQ and commercial DSP processes working with internal development teams and external clients to ensure successful operational execution.
- Lead hands on problem-solving efforts and root cause investigations to resolve deviations related to equipment, process or product and communicate the outcome of any investigation to internal and external customers.
- Provide direction to the development sites regarding the facility-fit of new processes and technical expertise for manufacturing scale processes across the Patheon network
- Support late-phase process validation programs including Process Characterization (PC), Risk Assessments and Control Strategy.
- Identify improvements and share best-practices across the network
- Generate, review and approve GMP documentation including Standard Operating Procedures (SOPs), Technical Transfer documents, Master Batch Records, Process Flow Diagrams and Bill of Materials
- Implement new technology and equipment within the production facility.
- Tertiary degree in Science or Engineering (preferably in biology, biotechnology, biochemistry, chemistry)
- Previous management experience is preferrable.
- More than 5 years in a biopharmaceutical GMP manufacturing environment or a Process Development lab / pilot plant.
- Knowledge of process development, scale-up and cGMP manufacturing of protein-based pharmaceuticals.
- Experience with scale up of purification unit operations including chromatography and micro/ultra/nano filtration.
- Experienced in leading RCAs and participating and leading Continuous Improvement (PPI) and Kaizen projects.
- Knowledge of FDA/EMA regulatory requirements and guidance applicable to biologics and how to apply to all aspects of the position.
- Biopharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable.
- Strong analytical and problem-solving skills.
- Ability to work in a matrix management system and influence and negotiate without direct authority.
- Effective planning, resource, and time management skills.
- Strong interpersonal and communications skills; written and oral, and a demonstrated decision-making ability.
- Proficient with IT systems including applications such as MS Office, Project and knowledge of controlled documentation and data systems. Experience with automation an advantage.
- A competitive salary and performance related bonus structure
- Access to Thermo Fisher’s global University
- Development opportunities as part of a rapidly growing global organisation