About Australia & New Zealand
Our growing team of 1200+ employees work together to deliver world-class science products and solutions to a wide range of key markets.
With commercial, manufacturing and distribution sites scattered across Australia and New Zealand, including Melbourne, Brisbane, Sydney, Auckland, Adelaide, Newcastle, and Perth.
Our scope covers life sciences, specialty diagnostics, food, dairy & beverage, environmental & industrial, healthcare and analytical instruments including commercial, customer service, technical service, supply chain, finance and operations.
How will you make an impact?
From leading the MBP team to manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA and ICH.
What will you do?
Build and nurture a high performing team through strong coaching, leadership.
Ensure growth and development of the Media and Buffer team with a focus on building talent depth.
Deliver sustained improvement in the site key performance indicators of Right the First Time and On Time Delivery.
Act as deputy in decision making process for MBP supervisor.
SME who is very experienced in the formulation of media and buffer solutions.
Strong background and prior experience in media / buffer formulation and aseptic practices and techniques.
As an SME of several unit operations and MBP equipment, supervise, train, coach and mentor co-workers that are unfamiliar with the certain unit operation or handling of specific equipment, including approval of on-the-job training.
Solid understanding of quality management systems; deviations and events, investigations and CAPAs, change control.
Support the MBP supervisor with scheduling, resource modelling and task allocation.
Independently organise unit operations in accordance with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
Perform equipment troubleshooting related to technical skills of Bioprocess Scientist IV.
Approve, Review, revise and author manufacturing production protocols.
Lead deviation investigations and change controls to streamline and improve internal processes.
Propose and implement Corrective and Preventive Actions and support the on-time closure Deviation Reports and Change Controls as well as writing Minor Deviation Reports.
Able to contribute to their Department functions, such as maintaining production suite, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.
Contributes to the transfer and understanding of specific new technologies to the OPS department.
Support and implementation of new procedures and / or equipment in the OPS department in consultation with other owners and users.
Revises assists in review and writes quality GMP documentation.
Communicates with suppliers about issues of technical nature.
Any reasonable additional tasks that might be required for day to day Operational activities.
How will you get here?
Preferably tertiary education in science or engineering based field (, biotechnology, process technology).
3+ years of relevant experience in the bio (pharmaceutical) fields or similar.
Very good knowledge in cGMP environment.
Knowledge, Skills, Abilities
Strong organisational, scheduling and planning skills.
Good communication, flexibility, reliability and assertiveness.
Demonstrated strong leadership skills to influence and build effective teams
A pro-active attitude and personal initiative is expected to identify and overcome practical problems, proposes a possible solution and communicates to the responsible person.
What’s in it for you?
Work in a collegial, customer focused and motivated team.
Work within a strong culture of process improvement with lots of great tools.
Access to global systems training and a network of highly qualified and experienced colleagues.
Ongoing learning and development opportunities on the job and through our own on-line Thermo Fisher University.
The Patheon Biologics site (Part of Thermo Fisher Scientific) in Brisbane manufactures many products for clinical trials and commercial applications.
This implies that the production activities range from executing a totally new production run for the first time, to the routine production of a commercial batch.
Due to the diversity of customers, and their associated products, the applicable processing steps are very diverse. Given the high value of the products and intermediates the Bioprocess Scientist has to be capable of judging the possible impact of a situation on product quality, yield, EH&
S and cGMP compliance. Due to involvement in the timely execution of manufacturing processes, a fair amount of discipline, organisational skills and flexibility in working hours are required