MS&T Process Specialist for Radiopharma

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

Job summary

Mariana Oncology, Inc. is seeking an experienced MS&T Process Specialist to own process knowledge from clinical to commercial radiopharmaceutical production.

You will serve as a technical steward, partner with CMC/Radiochemistry, and support deviations, CAPAs, and technology transfer, ensuring continuous inspection readiness. The role emphasizes rigorous problem-solving, collaboration across functions, and driving manufacturing excellence in a fast-paced environment, with a compensation summary

Qualifications

• Bachelor's degree in Chemical Engineering, Chemistry, Life Sciences, or related field.
• 3+ years in pharmaceutical manufacturing, MS&T, or cGMP environment.
• Experience in radiopharmaceuticals, sterile injectables, or small-volume parenteral manufacturing is preferred.

Responsibilities

• Act as SME for assigned process technologies and interface with MS&T network.
• Own process knowledge base including pilot scale, scale-up, and DoE.
• Collaborate with CMC/Radiochemistry to document process knowledge for assigned technologies.
• Benchmark processes and equipment to identify improvements.
• Support creation and revision of SOPs and lifecycle documents.
• Provide front-line technical support to manufacturing and ensure batch readiness.

Skills

Root cause analysis

CAPA management

Cross-functional

Technical writing

GMP knowledge

Data analysis

Change control

Process characterization

Education

Bachelor's degree in Chemical Engineering

Tools

Qualio

Job description

Mariana Oncology, Inc. is seeking an experienced MS&T Process Specialist to own process knowledge from clinical to commercial radiopharmaceutical production.

You will serve as a technical steward, partner with CMC/Radiochemistry, and support deviations, CAPAs, and technology transfer, ensuring continuous inspection readiness. The role emphasizes rigorous problem-solving, collaboration across functions, and driving manufacturing excellence in a fast-paced environment, with a compensation summary