Process Chemist

About the Role

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.

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

Accountabilities

• Take ownership over the projects you lead and feel a sense of accomplishment and pride in the work you produce
• Passionate about radiochemistry and the field of radiopharmaceutical science
• Planning, designing and executing development activities
• Ability to successfully lead multiple projects at a given time while maintaining quality
• Exhibit strong ability to multitask by prioritizing workload
• Excellent communication skills and ability to collaborate well with multiple stakeholders across the entire organization
• Strong oral and written communication skills
• Ability to work under minimal supervision and provide key updates to team members and management where required
• Attention to detail and well organized
• Excellent troubleshooting and analytical skills
• Thrive in a team setting and exhibit a high degree of trust and integrity
• Maintain the highest standards with respect to safety and radiation protection in all work activities
• Flexibility in work schedule to support a 7-day work week in support of nightshift-type production environment

Key Qualifications

• At 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. MSc or PhD in the abovementioned disciplines is preferred.
• 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.