Thermo Fisher Scientific in ANZ

Our growing team of 1400+ 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.

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

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

Job Title: Upstream Production Supervisor

Reports to USP Manager

Location: Brisbane, Australia

Direct Reports: up to 6

How you'll make an impact:

Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, etc.



What will you do?

• Responsible for leading the Upstream production team and demonstrating strong managerial aptitude in a fast paced, complex and dynamic regulated environment by managing multiple supervisors and team leaders (which includes a rotating 7 day roster).
• Build and nurture a high performing team through day-to-day coaching and leadership and ensuring growth and development of the Upstream Processing team with a focus on building talent depth and succession planning.
• Have specialised and concentrated knowledge in GMP Upstream processing and GMP facility management but with advanced knowledge in multiple disciplines across site (e.g. Downstream processing, QC, QA).
• Responsible for ensuring the Upstream and Operational processing technology keeps pace with novel and state-of-the-art processing equipment and techniques/technologies e.g. Perfusion technology, new Bioreactor technology and state of the art harvesting techniques such as single use centrifugation.
• Ensure the USP team supports the MSAT and Operational team on new process implementation and repeat batch execution at the site.
• Provides significant functional knowledge and tactical contribution for the operational and strategic site direction and ensuring the USP department can facilitate the site cadence and output requirements.
• Translates strategy into business success through implementation of relevant policies and procedures for the USP department while leveraging lean manufacturing principles / PPI principles and guides team to operate in a positive PPI driven culture.
• Deliver sustained improvement in the site key performance indicators of Right the First Time and On Time Delivery ensuring site meets KPI’s and ultimately timely delivery of therapeutics for patients.
• Independently organise and execute USP unit operations with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
• A pro-active attitude and personal initiative is expected to identify and overcome practical problems, proposes possible solution and communicates to the responsible person.
• Manage the implementation of new technologies
• Able to contribute in their USP and facility functions, such as maintaining production suite, supplies, equipment, logbooks, and data, as well as closing out batch record and material reconciliation in accordance with site SOPs and policies.
• Perform equipment testing and equipment troubleshooting related to skills of Bioprocess Scientist IV.
• Review, revise and author manufacturing batch records, SOPs, and logbooks.
• Write, execute and review validation protocols for which a USP Supervisor skillset is required.
• Monitor the execution of the production plan and take corrective actions, in order to achieve the results
• Fully trained on all USP unit operations and equipment as well as maintain up to date training matrix.
• As the SME of majority of USP unit operation or equipment, train co-workers that are unfamiliar with certain unit operation or handling of specific equipment, including approval of on-the-job trainings.
• Propose and implement corrective and preventive actions and drive the on-time closure of deviation reports and change controls.
• Being the lead investigator for minor and major deviation reports.
• Implement lean (OE) initiatives and continuous improvements with minimal directions.
• Contribute to the transfer and understanding of specific new technologies to USP.
• Support and implement new procedures and/or equipment in the OPS department in consultation with other owners and users.

How will you get here?

Education:

Tertiary education in science/ engineering-based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology) or 4 years of relevant experience in the bio (pharmaceutical) fields

Experience:

• Team management experience is preferred, with track record in building, developing and coaching a high performing team to deliver against objectives
• Very good knowledge and experience working in cGMP environment.
• Specific knowledge and experience in relevant quality systems.
• Demonstrated strong leadership skills to influence and build effective teams
• Excellent planning and organizational skills
• Strong organisational, scheduling and planning skills.
• Ability to work unsupervised.

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

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $40 billion and approximately 110,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner, and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market, and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.