Radiopharmaceutical MS&T Process Expert

Mariana Oncology; Watertown (MA); On-site; USD 74,000 - 137,000; Full time

Job summary

Mariana Oncology in Watertown, MA is seeking an experienced MS&T Process Specialist to lead manufacturing science and technology activities for radiopharmaceuticals. You will own process knowledge from clinical to commercial production and serve as SME, interfacing with operations, Quality, and CMC/Radiochemistry.

You will drive process characterization, equipment qualification, tech transfer, CAPA, investigations, and continuous improvement while ensuring inspection readiness and compliance

Qualifications

• Bachelor’s degree in Chemical Engineering, Chemistry, Life Sciences, or related field.
• 3+ years in pharmaceutical manufacturing, MS&T, or related cGMP environment.
• Experience with radiopharmaceuticals, sterile injectables, or small-volume parenteral manufacturing is preferred.
• Strong writing and cross-functional collaboration skills.

Responsibilities

• Act as process SME for assigned technology platforms and partner with CMC/Radiochemistry.
• Own process knowledge and documentation including DOE, design of experiments, and lifecycle records.
• Coordinate cross-functionally to ensure timely batch disposition and robust investigations.
• Lead deviation management, CAPA execution, and escalation packages.

Skills

Pharmaceutical manufacturing

MS&T experience

Deviations & CAPA

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering, Chemistry, Life Sciences, or related field

Tools

Qualio

Job description

Mariana Oncology in Watertown, MA is seeking an experienced MS&T Process Specialist to lead manufacturing science and technology activities for radiopharmaceuticals. You will own process knowledge from clinical to commercial production and serve as SME, interfacing with operations, Quality, and CMC/Radiochemistry.

You will drive process characterization, equipment qualification, tech transfer, CAPA, investigations, and continuous improvement while ensuring inspection readiness and compliance