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Usp Supervisor
3 months ago
About us
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.
Key Responsibilities:
- Lead the Upstream production team and demonstrate strong managerial proficiency in a fast paced, complex and dynamic regulated environment by leading multiple supervisors and team leaders on a rotating 7day roster.
- Build and nurture a hardworking team through daytoday coaching and leadership and 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 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 leveraging lean manufacturing principles / PPI principles and guides team to operate in a positive PPIdriven culture.
- Support Global network of USP managers to ensure innovation and driven enabling work projects can be prioritised and implemented across a multidimensional 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.
- 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 organizational 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.
- Physical Requirements / Work EnvironmentDue to involvement in the timely execution of manufacturing processes, interpersonal and organisational skills and flexibility in working hours are required.
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.
