USP Supervisor

7 days ago

Brisbane, Australia Thermo Fisher Scientific Full time

Work Schedule

Other

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Working at heights

Job Description

About us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Position Summary:

The Upstream (USP) team within Operations at Brisbane site carries out manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH and other regulatory bodies. We're looking for a USP Supervisor to join the existing team in Brisbane. If this sounds like you, we'd love to hear from you

Key Responsibilities:

  • Lead the Upstream production team and demonstrate strong managerial proficiency in a fast paced, sophisticated and dynamic regulated environment by leading multiple supervisors and team leaders on a rotating 7-day roster.
  • Build and nurture a hard-working team through day-to-day coaching and leadership and ensuring growth and development of the 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 subject areas across site (e.g. Downstream processing, QC, QA).
  • Responsible for ensuring the Upstream and Operational processing technology keeps pace with novel and innovative processing equipment and techniques/technologies e.g. 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 and 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 guides team
  • Support Global network of USP managers to ensure innovation and driven enabling work projects can be prioritised and implemented across a multi-dimensional Pharma Services group.
  • Deliver sustained improvement in the site KPI's 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 recognised sound and consistent approach when facing technical or personnel problems.
  • Independently organise 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.

Skills and Experience:

  • 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.

Due to involvement in the timely execution of manufacturing processes, interpersonal and organisational skills and flexibility in working hours are required.

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

We offer competitive compensation and benefits packages, along with opportunities for professional growth and development.  Watch as our colleagues explain 5 reasons to work with us.

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.

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