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 effectively with Manufacturing, QC, QA, Regulatory, and external partners.
- Ability to work independently, manage multiple priorities, and meet deadlines in a radiopharmaceutical environment.
Position RequirementsEducation 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 solutions to challenges
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
- Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
- Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
- Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
- Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
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.
