Manager, Process Engineering

6 months ago

Brisbane, Australia Thermo Fisher Scientific Full time

**About us**

At the Brisbane Pharma Services Group (PSG) Biologics site, we are a contract manufacturing organization (CMO) specialising in the production of biopharmaceuticals from mammalian cell culture. We provide manufacturing services including limited process development and “good manufacturing practice” cGMP grade drug substance to customers worldwide. These life-saving medicines help cure cancer, rheumatoid arthritis, wet age-related macular degeneration and other chronic and acute diseases.

***

The network of Patheon’s drug substance manufacturing sites includes St. Louis, USA, Groningen, Netherlands and Brisbane, Australia. The performance of each manufacturing site is linked closely the timely introduction of new projects, right-first-time manufacturing, and on-time delivery of products to customers.

**What will you do?**
- 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.

**How will you get here?**

**Education**:

- Tertiary degree in Science or Engineering (preferably in biology, biotechnology, biochemistry, chemistry)

**Experience**:

- 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.
- Biopharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable.

**Skills & Attributes**:

- 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.

**What’s in it for you?**
- 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

**Our Mission**

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

**Other Job Requirements**:
Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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