Production Lead (Downstream Specialist), Base Facility

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

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.

• 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. 

For more information about this opportunity, please contact Rachel Chang - ********@uq.edu.au

For application queries, please contact ******@uq.edu.au stating the job reference number (below) in the subject line. 
 

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

• Cover letter addressing the ‘About You’ section  
• Resume 
   

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 ******@uq.edu.au.

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.