About Telix Pharmaceuticals Limited

Telix is an Australian public company (ASX: TLX) headquartered in Melbourne with international operations in Europe, the US and Japan. Our mission is to be a leading, global biopharmaceutical company that delivers on the promise of precision medicine through targeted radiation, and we are currently developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases.

Job Description:
Technical Services Specialist

Type:
Full Time

Location:
United States

Date:
Immediate

About the Role

The ideal candidate will lead the development, implementation, and validation of manufacturing and analytical methods of new diagnostic and therapeutic radiopharmaceuticals for Telix Pharmaceuticals within the Manufacturing department. Working closely with Telix pharmaceutical partners, and Contract Manufacturing operations (CMO) they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and 212).

Responsibilities

  • Lead the development of protocols for the production and analysis of clinical/commercial-grade radiopharmaceuticals, validate these methodologies against quality requirements, and implement them for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards.
  • It is expected that the development of these protocols will involve both the application of scientific principles and rationales and adherence to regulatory requirements.
  • Technical support for our commercial product, Illuccix.
  • Write clear Standard Operating Protocols (SOPs) for these protocols.
  • Review existing SOPs and suggest logical modifications based on either scientific rationales and/or regulatory requirements.
  • Serve as lead technical support and/or training for production staff at Telix sites, CMOs either remotely or on-site.
  • Write corporate exception reports and other regulatory documents, such as risk assessments from the PMP, etc.
  • Conduct production or quality control analytical tests for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards.
  • Support to validate existing production or analytical methods on existing or new equipment
  • Lead the collaboration with other radiochemists as required to ensure successful protocol development and radiopharmaceutical production.
  • Maintain accurate radiopharmaceutical technology transfers documentation and test/validation results.
  • Write reports, presentations, and other documentation summarizing experimental/production data.
  • Coordinate with the Contract Manufacturing operation activities to reach defined objectives
  • Other duties as assigned by the Technical Services Manager-Radiochemistry or Radiochemistry Director

Qualifications

  • Bachelors’ Degree in chemistry, engineering, or natural sciences or equivalent work experience required
  • 1-3 years of experience in radiopharmaceutical manufacturing and QC in a GMP preferred
  • Expertise in laboratory procedures and analytical chemistry techniques (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.) required
  • Experience with the use of automated synthesis modules and maintenance of automated modules
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
  • Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification preferred
  • Efficient in the use of MS Office Suite
  • Ability to be detail-oriented, accountable, patient, organized, and work in a team environment with minimum supervision
  • Strong technical writing skills
  • Excellent organizational skills
  • Travel: up to 30 % domestically and international

Why Work at Telix?

We are a dynamic, fast-growing biopharmaceutical company where everyone counts. In addition to competitive salaries, we offer health and wellbeing incentives, bonus incentives and support for learning and development. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives.

How to apply

To register your interest, please apply here

Agency support is not required for this role and no submissions will be considered.