Australian Institute for Bioengineering and Nanotechnology (AIBN)
Join BASE Clinical Lab as the new Production Lead (Downstream
Specialist)
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 Production Lead (Downstream Specialist) at BASE Clinical, you will be
responsible for setting up Clinically-enabling Phase I manufacturing platforms
for mRNA and Lipid nanoparticle (LNP) formulation in a clean room
environment, and ensure the strategic goals of the facility are met.
You will be help deliver on equipment procurement and qualification, process
development and scale-up of the downstream purification unit operations, and
writing various technical documents such as URSs, SOPs and batch records etc.
You will oversee several stages of mRNA production (from raw material
preparation, mRNA synthesis and lipid nanoparticle formulation) ensuring the
overall performance, yield and quality attributes meet required
specifications.
Your role will be key in producing mRNA/LNP batches at scale and 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. Supervise
production scientists as the team grows by leading and motivating staff
members in achieving organisational goals.
Set up and operate clinically-enabling mRNA and LNP production
platform: Lead equipment procurement and qualification processes,
including SOP development and deployment. Manage and perform daily
mRNA/LNP production activities, including mRNA synthesis, purification,
and LNP formulation. Handle the day-to-day operations in the production
facility under a quality management system (QMS). This includes
directing the planning, implementation and execution around preparing raw
materials, operating production equipment, and performing the
manufacturing process according to specifications, timelines and KPIs.
Process Development: Manage and lead establishment of effective
scale-up of the mRNA manufacturing and formulation processes to a pilot
scale suitable for clinical manufacturing. Understand and manage
technical, logistical and operational issues of mRNA production and
purification processes, and develop solutions for troubleshooting and
improving efficiency and product quality.
Support Quality: You will adhere to the facility QMS and work closely
with the Quality team to ensure manufactured mRNA/LNP batches consistently
meet required specifications for release around quality, purity, and
safety.
Equipment Management and Maintenance : Oversee the operation and
maintenance of production equipment, and coordinate repairs and
calibrations.
Compliance and Documentation: Maintain, monitor, and document
accurate records of production processes, and work with the Quality team
to manage batch records, equipment logs, and quality control results.
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 coordinate with the supply
chain team to ensure the timely availability of necessary materials.
Collaboration: Work closely with other BASE Clinical departments,
such as R&D, Quality Control, Quality Assurance, Projects, Support and
Leadership, to ensure optimal production performance and address cross-
functional issues. Maintain collaborative working relationship with
external clients to ensure project activities are coordinated.
Reporting: Prepare and present regular reports on production
performance, challenges, and progress. Write, review, and approve
protocols and reports.
Client facing duties: Act as the primary client-facing 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 and may require shift
work and flexible hours depending on production needs. Work is performed in a
manufacturing plant environment with exposure to laboratory conditions.
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 3 years of experience in a similar operations role under a QMS
and with team leadership experience, preferably in the pharmaceutical or
biotechnology industry.
Process development experience in developing, scaling and troubleshooting
bioprocesses for downstream purification unit operations (e.g. TFF and
chromatography).
Knowledge of mRNA technology and formulation processes 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 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 work in a fast-paced and dynamic cross-functional
environment.
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-36416). Please note that interviews have been tentatively scheduled for
April.