Process Chemist

AtomVie Global Radiopharma•Hamilton, ON

55d•CA$0 - CA$67,000•Onsite

About The Position

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare. Reporting to the Lead, Radiopharmaceutical Technology, the Process Chemist will apply their technical expertise and experience in radiochemistry and process chemistry to support current products and future drug development within AtomVie’s portfolio of CDMO functions. The Process Chemist plays a vital role in the development of products through successful experiment design, execution, and data analysis of AtomVie’s clinical pipeline. The Process Chemist will work as part of a highly skilled group of individuals employing industry leading development activities within the radiopharmaceutical industry while ensuring regulatory compliance, site safety and radiation protection guidelines are continuously upheld. This hands-on role will work on site with some flexibility for remote work. Some weeknight and weekend work may be expected according to production schedules. This posting is for an existing vacancy to support the expansion of the company.

Requirements

Minimum BSc in chemistry, radiochemistry, biochemistry or equivalent discipline with at least 2 years of relevant laboratory experience and expertise in process development and formulation.
Strong knowledge in chemistry, process chemistry, or aseptic manufacturing experience in a pharmaceutical setting is considered an asset.
Knowledge of validation principles, technology transfer of manufacturing processes and GMP concepts is highly desirable.

Nice To Haves

MSc or PhD in chemistry, radiochemistry, or biochemistry is preferred.

Responsibilities

Act as a technical expert in GMP process development for AtomVie’s clinical and commercial portfolio
Design and conduct radiochemistry experiments for clinical and commercial drug developments
Critically evaluate data, determine appropriate conclusions and a plan of action in collaboration with internal stakeholders to develop phase-appropriate GMP production processes
Provide project data and progress status updates to management and clients
Work with cross-functional teams on the development of synthesis, purification, formulation and aseptic filling processes, including process transfer, scale-up, validation and launch activities
Support the preparation and review of written procedures, batch records, experimental protocols and reports, specifications and qualification/validation protocols
Prepare technical reports and documents, including SOPs and investigational reports
Emphasize safety in new and existing design and safe practices in all experimental activities for all staff members
Conduct work according to best practices and, where appropriate, regulatory guidance, GMPs, established business processes and protocols, and applicable standard operating procedures
Take ownership over the projects you lead and feel a sense of accomplishment and pride in the work you produce