Biopharmaceutical Production Lead

3 weeks ago

Brisbane, Queensland, Australia Thermo Fisher Scientific Full time
About the Role

We are seeking a highly skilled USP Supervisor to join our team in Brisbane, responsible for leading the Upstream production team and ensuring compliance with international quality requirements.

Key Responsibilities
  • Lead the Upstream production team and demonstrate strong managerial proficiency in a fast-paced, sophisticated, 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.
  • Responsible for ensuring the Upstream and Operational processing technology keeps pace with novel and innovative processing equipment and techniques/technologies.
  • 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, while using lean manufacturing principles/PPI principles and guiding the team.
  • Support 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 KPIs of Right the First Time and On Time Delivery, ensuring site meets Key Performance Indicators and ultimately timely delivery of therapeutics for patients.
  • Deputise 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 the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
  • 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 Quality Department to review and signoff on implemented 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.
  • Enforce to Patheon cGMP Quality Management System and the Patheon EH&S requirements.
Requirements
  • 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.
  • 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 interpersonal skills.
  • Specific knowledge of relevant bioprocess unit operations.
  • Strong organisational, scheduling, and planning skills.
  • Ability to work unsupervised.
  • Good communication, flexibility, reliability, and assertiveness.
  • Responsible and proactive.
Employee Benefits
  • A competitive salary and performance-related bonus structure.
  • Access to Thermo Fisher's global University.
  • Exposure to market-leading & innovative technologies.
  • Career development opportunities in a leading global organization.

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