Scientist II, Radiochemistry

telixus; Sacramento (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Telix Pharmaceuticals in the United States is seeking a Scientist II, Radiochemistry to support radiochemistry process development, transfer, and execution for GMP-regulated radiopharmaceuticals. The role emphasizes cross-functional collaboration with Manufacturing, QC, QA, Regulatory, and external partners.

Candidates will author, review, and maintain GMP documentation, apply ALARA radiation safety principles, and help advance our imaging agents used in oncology and rare diseases.

Qualifications

• Education: Ph.D. or M.S. in Radiochemistry or related field; B.S. with 5+ years in cGMP radiopharmaceuticals acceptable.
• Experience in radiochemical synthesis and radiopharmaceutical development and characterization.
• Familiarity with regulatory guidelines (cGMP, GLP, GDP) and data integrity.
• Hands-on radiochemical synthesis techniques, isotope production systems, HPLC, GC, MS, gamma spectroscopy.
• Proficiency in interpreting scientific data and reporting results clearly.

Responsibilities

• Author, review, and maintain GMP documentation (protocols, batch records, deviations, change controls).
• Support method development, method transfer, process validation, and manufacturing QC procedures.
• Collaborate cross-functionally with Manufacturing, QC, QA, Regulatory, and external partners.
• Ensure compliance with radiation safety protocols and ALARA principles.
• Contribute to regulatory submissions with high-quality documentation.

Skills

Radiochemistry

GMP environment

Data integrity

Analytical methods

HPLC

TLC

GC

Mass spectrometry

Gamma spectroscopy

Documentation

Education

Ph.D. in Radiochemistry

M.S. in Radiochemistry or related field

Tools

HPLC

GC

Mass Spectrometry

Gamma spectroscopy

Hot Cell with manipulator arms

Job description

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Scientist II, Radiochemistry will provide scientific and technical expertise to support the development, validation, transfer, and execution of radiochemistry processes for radiopharmaceutical products in a GMP-regulated environment. This role requires strong hands-on knowledge of radiochemistry principles, analytical methods, manufacturing and QC procedures, radiopharmaceutical process development, and radiation safety protocols. The successful candidate will be responsible for authoring, reviewing, and maintaining high-quality GMP documentation, including protocols, reports, batch records, SOPs, deviations, change controls, and supporting materials for regulatory submissions. This position will collaborate cross-functionally with Manufacturing, Quality Control, Quality Assurance, Regulatory, and external partners to ensure radiochemistry activities are scientifically sound, compliant, well documented, and aligned with applicable USP guidelines.

Key Accountabilities:

• Strong scientific expertise in radiochemistry, radiopharmaceutical process development, and radioactive material handling.
• Demonstrated experience working in a GMP-regulated environment with strong understanding of data integrity and audit-ready documentation practices.
• Ability to author, review, and maintain GMP documentation, including SOPs, batch records, protocols, reports, deviations, change controls, and validation records.
• Knowledge of radiation safety protocols, ALARA principles, contamination control, and safe handling of radionuclides.
• Experience with radiochemical analytical techniques and QC methods such as HPLC, TLC, GC, radio-TLC, dose calibrators, and related radiation safety instrumentation.
• Experience supporting method development, method transfer, process validation, and manufacturing and QC procedure implementation.
• Strong problem-solving skills with the ability to investigate technical issues, support root cause analysis, and implement scientifically sound corrective actions.
• Excellent written and verbal communication skills, with the ability to collaborate effective with Manufacturing, QC, QA, Regulatory, and external partners.
• Ability to work independently, manage multiple priorities, and meet deadlines in a radiopharmaceutical environment.

Position Requirements

Education and Experience:

• Education: A Ph.D. or M.Sc. degree in Radiochemistry, Chemistry, Nuclear Chemistry, or a related field is desired. A bachelor's degree with a minimum of five years of relevant experience and/or training in commercial cGMP radiopharmaceutical manufacturing is required.
• Experience: Demonstrated experience in radiochemical synthesis, radiopharmaceutical development and characterization techniques. Familiarity with modern analytical instrumentation and quality control methodologies is essential.
• Knowledge: Strong theoretical and practical understanding of radioisotope production methods, radiochemistry principles, and radiation safety protocols. Proficiency in interpreting and analyzing scientific data is crucial.
• Technical Skills: Hands-on experience with radiochemical synthesis techniques, radioisotope production systems, HPLC, GC, mass spectrometry, gamma spectroscopy and hot cell with manipulator arms. Proficiency in software tools for data analysis and scientific reporting.
• Regulatory Compliance: Familiarity with regulatory guidelines, including cGMP, GLP (Good Laboratory Practice), GDP (Good Documentation Practice) and radiation safety regulations. Experience working in a controlled laboratory environment is preferred.
• Collaboration and Communication: Strong interpersonal skills with the ability to work effectively in a multidisciplinary team. Excellent written and oral communication skills to convey scientific concepts and findings to both technical and non-technical audiences.
• Detail-oriented: Exceptional attention to detail, organization, and documentation skills to maintain accurate records, track experiments, and report results.

Key Capabilities:

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative