University of Queensland

University of Queensland

Quality Control Lead, BASE Facility

Australia

Expired

  • Australian Institute for Bioengineering and Nanotechnology (AIBN)

  • New opportunity for a Quality Control Lead at BASE Clinical Lab

  • Collaborate with world class researchers in state-of-the-art facilities

  • Be part of an organisation with a meaningful purpose and impact

  • Based at our vibrant St Lucia Campus

  • About UQ

    As part of the UQ community, you'll have the opportunity to work alongside the brightest minds, who have joined us from all over the world.

    Everyone here has a role to play. As a member of our professional staff cohort, you will be actively involved in working towards our vision of a better world. By supporting the academic endeavour across teaching, research, and the student life, you'll have the opportunity to contribute to activities that have a lasting impact on our community.

    Join a community where excellence is at the core of our culture, contributions are valued and a range of benefits and rewards are available, such as:

  • 26 weeks paid parental leave or 14 weeks paid primary caregiver leave
  • 17% superannuation contributions
  • 17.5% annual leave loading
  • Access to flexible working arrangements
  • Health and wellness discounts – fitness passport access, free yearly flu vaccinations, discounted health insurance, and access to our Employee Assistance Program for staff and their immediate family
  • On campus childcare options
  • Cheap parking (from just $5.75 a day)
  • Salary packaging options
  • About This Opportunity

    As the Quality Control Lead at BASE Clinical, you will be responsible for setting up QC laboratories for clinically-enabling Phase I mRNA materials and lipid nanoparticle formulations (LNP), and ensure the strategic goals of the facility are met. You will help deliver on equipment procurement, analytical assay development and qualification, and writing technical documents. You will oversee all aspects of the BASE Clinical's QC function in compliance with the facility Quality Management System and meeting relevant regulatory standards to meet Phase I clinical manufacture.

    Key responsibilities will include:

  • Leadership: Exercise ‘Supervisor' level leadership and management responsibility in accordance with the UQ Leadership Framework. Build and lead a QC unit responsible for setting up and operation of QC laboratories. Supervise QC scientists as the team grows by leading and motivating staff members in achieving organisational goals.
  • Set up and operate QC unit: Lead equipment procurement and analytical assay development and qualification, including SOP development and deployment. Handle the day-to-day operations of QC laboratories under a quality management system (QMS). This includes directing the planning, implementation, and execution around QC testing of mRNA and LNP formulations, operating QC equipment, and performing QC analytics according to the protocol, timelines and KPIs.
  • QC systems: Manage and lead QC systems and procedures for testing and releasing of phase-appropriate clinical mRNA materials. Manage all QC test procedures including environmental monitoring. Approve specifications, sample management, analytical test methods and other procedures related to QC.
  • Equipment Management and Maintenance : Oversee the qualification, operation, and maintenance of QC equipment, and coordinate repairs and calibrations.
  • Compliance and Documentation: Maintain, monitor, and document accurate records of QC data in compliance with the facility QMS.
  • Safety Management: Uphold a safe working environment by enforcing safety protocols and conducting regular safety audits. Address any safety concerns promptly and effectively.
  • Inventory Management: Monitor and manage inventory levels of consumables and equipment. Manage budgeting and ensure the timely availability of necessary materials.
  • Collaboration: Work closely with other BASE Clinical departments, such as R&D, Production, Quality Assurance, Projects, Support and Leadership, to ensure optimal performance and address cross-functional issues. Maintain collaborative working relationship with external clients to meet project timelines.
  • Reporting: Prepare and present regular reports on QC performance, challenges, and progress. Write, review, and approve protocols and reports.
  • Client facing duties: Act as the primary client-facing QC technical liaison to understand their needs, address concerns and drive collaborative solutions for successful project execution.
  • This role is subject to The University's Code of Conduct.

    This is a full-time (100%), fixed-term position for up to 2 years.

    At HEW level 8, the full-time equivalent base salary will be in the range $108,975.08 - $122,176.31, plus a generous super allowance of up to 17%. The total FTE package will be up to $127,500.84 - $142,946.29 annually. As this role is covered by an Enterprise Agreement, you will also receive regular remuneration increases – at least once a year.

    About You
  • Postgraduate qualifications in Biotechnology, Bioengineering, Pharmaceutical Sciences, or related field or combination of relevant industry and management experience.
  • Minimum of 5 years of experience in a similar operations role under a QMS and with team leadership experience, preferably in the pharmaceutical or biotechnology industry in QC testing roles.
  • Practical experience of analytical sciences and technologies, analytical method development and qualification, QC testing and release of clinical materials for clinical trials.
  • Prior experience in mRNA and LNP formulations preferred.
  • Strong leadership and team management skills with experience mentoring team members. Experience building and leading teams and in establishing and monitoring departmental goals and metrics.
  • Excellent problem-solving and analytical abilities.
  • Technical writing skills and proficiency in investigations and root cause analysis.
  • Deep understanding of quality governance and working in a regulated environment or working under a QMS. Familiarity with regulatory requirements in pharmaceutical manufacturing (e.g., TGA cGMP, PIC/S) preferred.
  • Proven ability to assess risk, collaborate with support groups to develop suitable action plans, and minimise potential impact.
  • Strong communication and interpersonal skills with the ability to communicate with clarity across all functional groups and levels of the organisation.
  • Ability to multitask and be agile in a fast-paced and dynamic, cross- functional environment.
  • Employ strong analytical and problem-solving skills to manage shifting priorities, demands and timelines.
  • In addition, the following mandatory requirements apply:

  • Work Rights: You must have unrestricted work rights in Australia for the duration of this appointment to apply. Visa sponsorship is not available for this appointment.
  • Background Checks: All final applicants for this position may be asked to consent to a criminal record check. Please note that people with criminal records are not automatically barred from applying for this position. Each application will be considered on its merits.
  • Questions?

    For more information about this opportunity, please contact Rachel Chang - [email protected]

    For application queries, please contact [email protected] stating the job reference number (below) in the subject line.

    Want to Apply?

    All applicants must upload the following documents in order for your application to be considered:

  • Cover letter addressing the ‘About You' section
  • Resume
  • Other Information

    At UQ we know that our greatest strengths come from our diverse mix of colleagues, this is reflected in our ongoing commitment to creating an environment focused on equity, diversity and inclusion. We ensure that we are always attracting, retaining and promoting colleagues who are representative of the diversity in the broader community, whether that be gender identity, LGBTQIA+, cultural and/or linguistic, Aboriginal and/or Torres Strait Islander peoples, or people with a disability. Accessibility requirements and/or adjustments can be directed to [email protected].

    If you are a current employee (including casual staff and HDR scholars) or hold an unpaid/affiliate appointment, please login to your staff Workday account and visit the internal careers board to apply for this opportunity. Please do NOT apply via the external job board.

    Applications close 11 April 2024 at 11.00pm AEST (Job Reference Number – R-36953). Please note that interviews have been tentatively scheduled for April.

    Job details

    Title

    Quality Control Lead, BASE Facility

    Employer

    University of Queensland

    Location

    Australia

    Published

    March 22, 2024

    Application deadline

    April 11, 2024

    Job type

    Administration/Managerment

    Field

    Biology,Chemistry,Engineering,Medicine,Physics

    About the employer

    The University of Queensland (UQ) is one of Australia’s leading research and teaching institutions. UQ strive for excellence through the creation, preservation, transfer and application of knowledge. For more than a century, this university has educated and worked with outstanding people to deliver knowledge leadership for a better world.

    Since it was founded in Brisbane in 1909, UQ has provided exceptional study experiences, research excellence and collaborative partnerships, coupled with an unforgettable lifestyle and stunning climate, to deliver knowledge leadership for a better world. With 3 campuses and more than 40 teaching and research sites, UQ is the perfect place to teach, research and study. Take advantage of the extensive UQ features including the largest research library in Queensland, hundreds of quality study spaces, several museums, a theatre, 11 college residences, and magnificent sporting facilities, such as swimming pools, tennis, basketball and volleyball courts, sports fields, Olympic-standard running tracks, and gymnasiums.

    Our high-quality range of around 390 undergraduate and postgraduate programs is one of the most comprehensive in Australia, providing students with the latest and most advanced disciplinary knowledge and industry placements informed by UQ’s world-leading research. UQ’s 6 faculties, 8 globally recognised research institutes and 100+ research centres attract an interdisciplinary community of more than 2,000 scientists, social scientists and engineers, who continue UQ’s tradition of research leadership.

    As you enjoy Queensland’s stunning campuses and climate, you can also make the most of the University’s proximity to many natural wonders – including beautiful beaches, lush rainforests, outback deserts, the Great Barrier Reef, as well as the largest sand island in the world – and visit stunning tourist attractions within an hour’s drive, such as the Gold and Sunshine Coasts, Byron Bay, Lone Pine Koala Sanctuary, and the world-famous ‘Australia Zoo’. Within Australia, Brisbane is renowned as a friendly and affordable city, with plenty of dining and entertainment attractions, and was ranked by The Economist Intelligence Unit’s 2019 Global Liveability Index as the world’s 18th most liveable city, achieving a perfect score for education and healthcare.

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