Medical Devices

2 weeks ago

Perth, Western Australia Fuse Recruitment Full time

As the Production Manager you will lead the production team to deliver radiopharmaceutical products for clinical trials. This role is based in the Western Suburbs of Brisbane with relocation support for interstate candidates on offer.

Who will you be working with?

Our Client is a clinical stage radiopharmaceutical company developing treatments to significantly improve survival and quality of life for patients with cancer. As they continue to make advancements in their product development and clinical phases, there are opportunities to be part this high-performing team who are experts in their field.

As the Production Manager you will play a key role in leading the Radiopharmaceutical manufacturing team, scheduling production batches, supporting the development of products, facilitating the introduction of GMP manufacturing systems and ensuring supply of quality product for clinical trials.

What are the benefits?

  • Brand new role
  • Competitive salary package + relocation support (if required)
  • Gain valuable experience working under a range of quality and regulatory frameworks as the products evolve to commercialisation
  • Culture of teamwork towards common goals

What will you be doing?

As the Production Manager you will bring your expertise to guide the small manufacturing team to deliver on key timelines ensuring that these critical products are manufactured to essential specifications and regulatory requirements.

As these products have a short shelf-life (hours, not months), the manufacturing timelines are critical and you will need to bring strong capability to analyse data, troubleshoot and make decisions to release products on time. As the company evolves from R&D production to commercial production there will be a need to apply GMP guidelines to meet quality and regulatory requirements such as TGA and FDA.

Note that this team performs some early morning starts and night shifts, however this position will be required to work Monday to Friday 9am – 5pm.

Key tasks of this role include:

  • Plan, schedule and oversee manufacture of radiopharmaceutical APIs;
  • Trouble shoot any issues that arise to ensure manufactured products are released and shipped in strict timelines;
  • Work closely with QA to improve, optimise and validate manufacturing processes, close out deviations and participate in audits and investigations;
  • Adapt to evolving regulatory and quality requirements as the organisation transitions from R&D to commercial scale manufacturing;
  • Manage and develop a small team of Scientists.

What do you need?

This role requires strong knowledge of how to manufacture pharmaceuticals, radiopharmaceuticals and/or sterile injectables. A background in organic chemistry, nuclear medicine or similar would also be applicable to the technical needs of this position.

Whilst there will be movement towards TGA, FDA, EMA and GMP requirements, the initial production processes will meet clinical trial requirements, so if you do not have a strong background in GMP but have excellent knowledge of radiopharmaceuticals or nuclear medicines then we encourage you to apply.

Other key requirements of this role include:

  • A tertiary qualification in Radiopharmacy, Nuclear Medicine, Chemistry or equivalent;
  • A strong understanding of manufacturing scale up with the ability to plan and schedule production, inventory and supply chain needs;
  • Proven experience solving problems related to analytical procedures or manufacturing optimisation;
  • Previous experience in a lead production position managing a team to deliver KPIs;
  • A minimum of 2 years in a leading production position with the ability to effectively lead and grow teams.

Note that this role is working with radiation products in a safety controlled and regulated environment so you must be comfortable working in this environment and maintaining a Queensland Radiation Use Licence (provided by the company).

Apply now or, if you have any questions, please contact Emma Chung on

At Fuse, we specialise in recruitment for the scientific and manufacturing industry, and actively source a variety of roles for a broad range of organisations. If you are looking for a new opportunity, we'd love to hear from you

If you know someone looking for a job, refer them to us and we'll give you $500* if we find them a new role

#SCR-emma-chung-1
#ChooseFuse

Consultant

Emma Chung

Senior Recruitment Consultant



Reference number: BH
Profession:Science & TechnologyOther

Company: Fuse Recruitment
Date posted: 17th Jun, 2024

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