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.