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Scientist II, Radiochemistry

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor’s degree and 5+ years experience or Master’s degree and 3+ years experience, GMP level radiochemistry experience required, Experience with HPLC, TLC, or GC QC methods preferred, Experience in GMP-compliant manufacturing is required, Strong written and verbal communication skills.

Key responsabilities:

Interface with stakeholders to manage development of manufacturing and QC procedures
Manage analytical method transfer process to new facilities
Generate protocols and reports to support regulatory filings
Develop and validate manufacturing and non-compendial QC procedures
Provide technical support for all Telix products

Telix Pharmaceuticals Limited Biotech: Biology + Technology Scaleup https://www.telixpharma.com/

201 - 500 Employees

See more Telix Pharmaceuticals Limited offers

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

Telix is seeking applicants for a Radiochemist position to support the development of its commercial stage radiopharmaceutical assets. The successful candidate will be responsible for managing the development required to ensure manufacturing and QC procedures meet the corporate requirements to support clinical trials, and regulatory submissions. This is an ideal role for radiochemists with experience manufacturing under GMP regulations who are comfortable in a fast-paced environment and who are motivated to make vital contributions to the next generation of radiopharmaceutical drugs.

Key Accountabilities

Interface with key stakeholders, including external CMOs, to manage the development of manufacturing and QC procedures for clinical and commercial stage radiopharmaceutical assets in compliance with all applicable GMP regulations.
Manage the manufacturing and analytical method transfer process to new manufacturing facilities.
Manage the development and validation of manual or automated manufacturing procedures as required.
Manage the development and validation of non-compendial QC procedures as required.
Generate development, validation, method transfer, and various other types of protocols and reports to support regulatory filings for commercial drug products.
Support regulatory filings via completion of CMC sections for INDs, NDAs, and foreign equivalents.
Generate SOPs for manufacturing and QC procedures.
Provide technical support for manufacturing and QC procedures for all Telix products as required.
Ensure all documentation generated is consistent with Telix QMS and general principles of GMP manufacturing.

Education and Experience

Bachelor’s degree plus 5+ years' experience, or Masters degree plus 3+ years' experience required
GMP level radiochemistry experience is required.
Experience transferring HPLC, TLC, or GC QC methods for radiopharmaceuticals is required.
Experience working on GMP-compliant manufacturing is required.
Strong written and verbal communication skills are required.
Experience working with fluorine and iodine radiochemistry is preferred.
Experience of method/process development to support regulatory filings is preferred.

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. 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. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

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