USP Supervisor

2 weeks ago

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

Job Summary:

We are seeking a highly skilled USP Supervisor to join our team at Thermo Fisher Scientific. As a USP Supervisor, you will be responsible for leading the Upstream production team and demonstrating strong managerial proficiency in a fast-paced, complex, and dynamic regulated environment.

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 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 (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 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 leveraging lean manufacturing principles / PPI principles and guides team to operate in a positive PPI-driven culture.
* 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 key performance indicators 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.
* 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 Quality Department to review and signoff 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 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 organisational 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.

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 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, interpersonal and organisational skills and flexibility in working hours are required.

About Us:

We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. If you are a motivated individual with a passion for demand planning and inventory management, we invite you to apply for this exciting opportunity.

Equal Employment Opportunity:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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