Scientist/Sr. Scientist , CMC Radiochemistry (on-site in SSF)

Who we are

What we look for

Salary Range: 125k – 160k

Principal Responsibilities

• Conduct radiochemistry experiments leading to robust radiolabeling processesand clinical formulations that meet target product profiles for diagnostic and therapeutic applications.
• Design and conduct experiments, critically evaluate data, draw appropriateconclusions, and develop a follow-up plan of action.
• Collaborate with multidisciplinary teams to define development project goalsand timelines.
• Execute quality control testing and develop product and in-process controls specifications for radiopharmaceutical drug products in conjunction with staff analytical scientists.
• Troubleshoot, identify unusual results and design experiments that establishroot 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 progressstatus updates to internal cross-functional project team.
• Help to technology transfer package for transfer of radiolabeling and analytical methods to third party CDMO partners and serve as a representative on aproject team in the capacity of process chemist expert.
• Recommend and implement continuous improvements with respect to safe handling of radioactive substances in the laboratory environment according to the radiation safety manual requirements.
• Maintain a safe working environment in adhering to the radiation safety manual requirements and support ad-hoc tasks as set in the policies (eg.:conduct area radiation surveys, contamination control, radioactive waste management).
• Ensures compliance with Health and Safety, policies, procedures andregulations applicable to the work.
• Maintain the routine operations of the laboratories, including (but not limitedto), inventory counts, consumables ordering processes, first line equipmentmaintenance.
• Conduct work according to best practices and where appropriate, regulatory guidance, international pharmacopeias, ICH, established protocols and standard operating procedures.

Qualifications, Education & Experience

• PhD/MSc in Radiochemistry, Chemistry, Analytical Chemistry, NuclearEngineering or equivalent knowledge or experience
• 5+ years’ experience with academic and/or industrial radiopharmaceuticalprocess development, formulation development, production, or tech transfer.
• Experience in method and formulation development to support regulatory filingsis preferred.
• Hands on experience in radiolabeling with radioisotopes (radiometals preferred)used for diagnostic and therapeutic applications; experience with alpha emittersis a plus.
• Experience with radiotracer analytical techniques, including High Performance
• Liquid Chromatography (HPLC), Radioactive detectors, Thin Layer
• Chromatography (TLC), pH meter, Osmometer preferred.
• Hands-on experience with automated radio synthesizing units is preferred

Skills and Abilities

• Strong knowledge of the radioactive material handling regulations, includingCDPH, NRC, IAEI.
• Functional knowledge of radiopharmaceutical process/formulation chemistry, standard concepts of radiochemistry, best practices, regulatory requirements for development of radiopharmaceuticals in various jurisdictions.
• Ability to plan and execute complex scientific projects. Strong analytical andtrouble shooting skills.
• Ability to handle more than one project at a time, multitasking, effectivecommunicator and collaborative with different teams.
• Ability to lift and carry heavy weighing up to 50 lbs.

• Competitive Base Pay: Our expected base pay range for this position is $125k - $160k (USD), plus performance-based bonuses.
• Comprehensive Benefits: Health, Dental, Vision, Prescription drug coverage, Basic Life and AD&D insurance, both Long-Term and Short-Term disability 16 paid company holiday, 20 days of PTO and 6 sick days to ensure your well-being, as well as a 401k plan with up to 3.5% company match, equity and bonus to help secure your financial future.
• Personalized Pay: Your individual pay will be determined by your job-related skills, experience, and relevant education or training, ensuring you receive fair and competitive compensation.
• Work-Life Balance: We also offer a hybrid work schedule with 3 days on-site along with development and growth opportunities.
• At Abdera, we value our employees and strive to create an environment where you can thrive both professionally and personally. Join us and be part of a company that cares about your growth and well-being.