Manager, Process Engineering (DSP)

at  Thermo Fisher Scientific

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.

POSITION SUMMARY:

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.
As Manager, Process Engineering (DSP) you lead the DSP Process Engineering team responsible for successful transfer of new projects. You will train and mentor staff, driving harmonization, assisting with global projects, and major site deviations/issues. The successful candidate will be a highly motivated self-starter who is able to assimilate new information quickly and enjoys cross-department collaboration within a fast-paced project execution environment.

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.
• 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.

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.
• Proficient with IT systems including applications such as MS Office, Project and knowledge of controlled documentation and data systems. Experience with automation an advantage.

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

• 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.