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Senior Scientist, Radiochemistry CMC
2 months ago
About UsAlpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities. Position SummaryAlpha-9 is seeking a Scientist/Sr. Scientist, CMC Radiochemistry to join our growing organization. The ideal candidate will develop radiolabeling processes and analytical testing methods for targeted, peptide/small molecule-based radiopharmaceuticals will be responsible for developing and delivering novel radiolabeled diagnostic and therapeutic compounds for both pre-clinical and clinical applications with a technology transfer to our CDMO partners.This position requires a high degree of collaboration, multi-tasking ability, and desire to strive in a fast-paced environment. You will have the opportunity to contribute to the build-out and set-up of new laboratory facilities and interface with external partners.Some specific duties and tasks include, but are not limited to, the following:Conduct radiochemistry experiments leading to robust radiolabeling processes and clinical formulations that meet target product profiles for diagnostic and therapeutic applications.Design and conduct experiments, critically evaluate data, draw appropriate conclusions and develop follow-up plan of action.Work in multidisciplinary teams to define development project goals and timelines.Develop quality control procedures, analytical methods and specifications for finished radiopharmaceutical drug products in conjunction with staff analytical chemists.Develop technology transfer package for transfer of radiolabeling and analytical methods to third party CRO and CDMO partners and serve as a representative on a project team in the capacity of process chemist expert.Ability to troubleshoot, identify unusual results and design experiments that establish root cause and/or enhance knowledge of the product being developed.Author, revise and review technical documents including SOPs, development reports, test methods, experimental and qualification protocols, batch records, specifications and regulatory documents. Provide project data and progress status updates to internal cross-functional project team.Suggest and implement continuous improvements with respect to safe handling of radioactive substances in the laboratory environment according to applicable Nuclear Safety Regulations (Canadian Nuclear Safety Commission).Adhere and follow radiation safety regulations as set in the policies and conduct area radiation surveys, contamination control, radioactive waste management.Ensures compliance with Health and Safety, policies, procedures and regulations applicable to the work.Conduct work according to best practices and where appropriate, regulatory guidance, international pharmacopeias, ICH, established protocols and standard operating procedures.QualificationsPhD/MSc in Radiochemistry, Chemistry, Analytical Chemistry, Nuclear Engineering or equivalent knowledge or experience2+ years’ experience (Scientist) to 5+ years’ experience (Sr. Scientist) with academic and/or commercial radiopharmaceutical process development, formulation development, production, or tech transfer.Hands on experience in radiolabeling with radioisotopes used for diagnostic and therapeutic applications; experience with alpha emitters is a plus.Ability to plan and execute complex scientific projects. Strong analytical and trouble shooting skills.Ability to handle more than one project at a time, multitasking, effective communicator and collaborative with different teams.Functional knowledge of radiopharmaceutical process/formulation chemistry, standard concepts of radiochemistry, best practices, regulatory requirements for development of radiopharmaceuticals in various jurisdictionsWhat’s in it for you:· Full extended health and dental benefits· Competitive Salary, Bonus, and Equity· Commuter Reimbursement· Group Registered Retirement Savings Plan with 5% employer match· 20 vacation days· 14 Holidays· 5 Sick Days· Long Term Disability· Life Insurance· Impactful rewarding work
