USP Supervisor

2 days ago

Brisbane, Queensland, Australia Thermo Fisher Scientific Full time
Job Title: USP Supervisor

Thermo Fisher Scientific is seeking a highly skilled and experienced USP Supervisor to lead our Upstream production team in Brisbane. As a key member of our team, you will be responsible for ensuring the smooth operation of our manufacturing processes, maintaining high-quality standards, and driving continuous improvement.

Key Responsibilities:
  • Lead the Upstream production team and demonstrate strong managerial proficiency in a fast-paced, complex, and dynamic regulated environment.
  • Build and nurture a hard-working team through day-to-day coaching and leadership, ensuring growth and development of the team with a focus on building talent depth and succession planning.
  • Have specialized and concentrated knowledge in GMP Upstream processing and GMP facility management, with advanced knowledge in multiple subject areas across site (Downstream processing, QC, QA).
  • Responsible for ensuring the Upstream and Operational processing technology keeps pace with novel and innovative processing equipment and techniques/technologies (Perfusion technology, new Bioreactor technology, and innovative 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.
  • Provide significant functional knowledge and tactical contribution for the operational and strategic site direction, ensuring the team can facilitate the site cadence and output requirements.
  • Translate strategy into business success through implementation of relevant policies and procedures for the team, leveraging lean manufacturing principles/PPI principles, and guiding the team to operate in a positive PPI-driven culture.
  • Support the Global network of USP managers to ensure innovation and driven enabling work projects can be prioritized and implemented across a multi-dimensional Pharma Services group.
  • Deliver sustained improvement in the site key performance indicators of Right the First Time and On Time Delivery, ensuring the site meets Key Performance Indicators and ultimately timely delivery of therapeutics for patients.
  • Deputize for the USP Manager when they cannot be present, as well as demonstrate leadership and accountability.
  • Possess a high level of independence, along with a recognized sound and consistent approach when facing technical or personnel problems.
  • Independently organize and implement USP unit operations with applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
  • 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.
  • Review, revise, and author manufacturing batch records, SOPs, and logbooks.
  • Collaborate with the Quality Department to review and sign off on executed batch records.
  • Write, implement, and review validation protocols.
  • Supervise the execution of the production plan and take corrective actions, in order to achieve the results.
  • Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements.
Requirements:
  • Tertiary education in a science/engineering-based field (biopharmaceuticals manufacture, biotechnology, process technology) or > 4 years of relevant experience in the bio(pharmaceutical) fields.
  • Good knowledge and experience working within a cGMP environment.
  • Specific knowledge and experience in relevant quality systems.
  • Proven strong leadership skills to influence and build effective teams.
  • Excellent planning and organizational skills.
  • Specific knowledge of relevant bioprocess unit operations.
  • Strong organizational, scheduling, and planning skills.
  • Ability to work unsupervised.
  • Good communication, flexibility, reliability, and assertiveness.
  • Responsible and proactive.
Work Environment:

The Thermo Fisher Scientific site in Brisbane manufactures many products for clinical trials and commercial applications. 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 Team Leader must 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, interpersonal and organizational skills, and flexibility in working hours are required.

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