Hybrid Scientist I, Analytical Development & Quality Control na Alpha-9 Oncology
Alpha-9 Oncology · Vancouver, Canadá · Hybrid
- Junior
- Escritório em Vancouver
Your Impact
Alpha-9 Oncology is seeking a highly motivated and skilled Scientist with a strong background in analytical method development of radiopharmaceuticals to join our dynamic Analytical Development team. You’ll contribute to the development, qualification, and transfer of analytical methods for novel targeted, peptide/small molecule-based radiopharmaceuticals while closely collaborating with cross functional groups such as process/formulation development and discovery. You'll have the chance to make a real impact on our mission while enjoying a dynamic work environment that fosters learning and career progression.
Reporting to the Director of Analytical Development and Quality Control, you will play a key role in shaping our analytical platform and supporting the advancement of novel radiolabeled compounds into preclinical and clinical development. Your work will include developing and documenting analytical test methods, generating comprehensive reports and procedures, and ensuring seamless technology transfers to CDMO partners – ultimately supporting the quality and integrity of our life-changing radiopharmaceutical products. This role is based in our Vancouver office.
How You'll Contribute
- Design, develop, and qualify robust analytical methods for radiopharmaceutical drug substances and products to support QC release and ensure suitability for their intended purpose.
- Develop and optimize analytical methods across various platforms, such as HPLC (UV detection, radio detection and/or fraction collection with subsequent gamma counting), radio-TLC, LC-MS, mass spectrometry and gamma spectroscopy.
- Perform routine and non-routine analysis of starting materials, in-process samples, drug substances, and drug products, interpret complex data, and document findings to support process development, stability studies, and manufacturing operations.
- Troubleshoot analytical instrumentation and methods, analyze discrepancies, identify root causes, and implement effective corrective actions.
- Generate comprehensive pre-qualification reports and analytical test method procedures and analysis templates to enable seamless technology transfer to our CDMO partners.
- Author and review technical documents, including method development reports, qualification/validation protocols and reports, standard operating procedures (SOPs), and analytical sections for regulatory submissions.
- Monitor and trend analytical and process data to evaluate method performance, identify critical steps, and establish robust specifications and acceptance criteria.
- Collaborate effectively with cross-functional teams internally and externally, including Process Development, Quality Control, Manufacturing, and Quality Assurance, to advance projects efficiently and present scientific findings clearly.
- Maintain strict adherence to radiation safety protocols, including area surveys, contamination control, and waste management, while fostering a strong culture of safety, quality, and continuous improvement.
- Ensure compliance with Health and Safety policies, procedures and regulations applicable to work.
The Skills You Bring
- Ph.D. in Analytical Chemistry, Radiochemistry, Pharmaceutical Sciences, or a related field, with at least 1 year of industry experience (postdoctoral experience may be included); or an MS with at least 4 years of relevant experience.
- Extensive hands-on experience is required across a variety of analytical techniques, including Chromatography (HPLC/UPLC, for small molecules and peptides, and GC), Spectroscopy (UV-Vis and Gamma Spectroscopy, ), and Radiochemical methods (Radio-HPLC, Radio-TLC, dose calibrator operation, and radionuclide identification).
- Strong understanding and practical application of cGMP, ICH guidelines, and regulatory requirements (e.g., FDA, EMA) pertaining to analytical method development, qualification, and validation in the pharmaceutical industry.
- Proficiency in data analysis software and statistical tools (e.g., JMP, Minitab, Excel) for interpreting analytical results and drawing sound conclusions.
- Excellent problem-solving skills and a proven ability to design, execute, and analyze experiments effectively.
- Strong written and verbal communication skills with the ability to present complex scientific data clearly, concisely, and persuasively to diverse audiences.
- Experience in a radiopharmaceutical environment is highly desirable.
- Familiarity with handling radioactive materials and strict adherence to associated safety protocols is a significant advantage.
What's in it for you
At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.
Company Summary
Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.
Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.
More about Alpha-9 Oncology
Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.
We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.