What are the responsibilities and job description for the Director, Technology Development position at Mariana Oncology?
Description:
We are seeking an experienced Director, Technology Development to join Mariana’s Technical Operations organization, advancing personalized medicine and radiopharmaceuticals. This role will support the technology development and technology transfer activities for new radiopharmaceuticals and key developmental lifecycle radiopharmaceutical products. This person will collaborate with internal and external stakeholders to ensure the development and transfer of robust manufacturing processes compliant with current Good Manufacturing Practices (cGMP) in a phase-appropriate manner.
Illustrative Breadth of Responsibilities:
- Provide strategic leadership in driving technology development for key lifecycle injectable radiopharmaceutical products, ensuring successful process performance and scalability.
- Drive process automation efforts, including the integration and optimization of automated chemistry modules and radiopharmaceutical production systems.
- Oversee the design, preparation, and review of experimental plans, methods, and protocols related to process development, including collaboration with Supply Chain for vendor selection and technical assessments.
- Lead efforts in Design of Experiments (DOE) and Process Risk Assessment (FMEA) to establish robust Process Control Strategies (PCS) for radiopharmaceutical manufacturing.
- Mentor a multidisciplinary team of engineers and scientists focused on the development, optimization, and troubleshooting of manufacturing processes.
- Serve as a subject matter expert in regulatory submissions, contributing to Chemistry, Manufacturing, and Controls (CMC) documentation in collaboration with external partners and cross-functional teams.
- Promote and enforce safety standards, ensuring compliance with good safety practices and the use of protective equipment.
- Actively embody and promote Mariana’s values in all professional activities and foster a culture of innovation and collaboration.
Requirements/Skills:
- B.S. in relevant scientific/technical disciplines; advanced degree(s) or certifications in process automation or radiopharmaceutical technologies are a plus.
- 8 years of work experience within the radiopharmaceutical or related industries, with a focus on technology development and process automation.
- Expertise in radiopharmaceutical production automation, including the implementation and operation of automated chemistry systems (e.g., All-in-One, Neptis, FastLab).
- Proven experience in process development for aseptically filled/finished drug products, medical devices, or radiopharmaceuticals.
- Strong understanding of regulatory requirements, cGMPs, and working within a compliance-driven environment.
- Familiarity with Design of Experiments (DOE), Quality by Design (QbD), and Quality Risk Management (QRM) principles.
- Demonstrated leadership experience in managing technical teams and multiple complex projects.
- Excellent analytical, problem-solving, and technical communication skills.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Project.
Mariana Oncology’s Principles
- Building a Legacy
- Execution Excellence
- Courage of our Convictions
