MS&T Process Expert — Radiopharma Manufacturing

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

Job summary

Mariana Oncology is seeking an experienced MS&T Process Specialist to join our Manufacturing Science and Technology organization in the U.S. This role acts as the SME for assigned processes, owning deep process knowledge from clinical through commercial production and coordinating with CMC/Radiochemistry to ensure robust manufacturing.

The ideal candidate has a track record in deviation management, root cause analysis, CAPA authorship, and change control in a cGMP environment, with experience

Qualifications

• Demonstrated expertise in deviation management, root cause analysis, CAPA authorship, and change control.
• Familiarity with GMP regulations (FDA 21 CFR Parts 210/211) and QA/GxP practices.
• Experience supporting technology transfer from development to GMP manufacturing.
• Proven ability to write clear investigations and impact assessments.
• Strong communication across site functions and with external partners.

Responsibilities

• Serve as SME for assigned process technologies, interfacing with MS&T network.
• Own process knowledge base, including pilot scale, scale-up and DoE activities.
• Collaborate with CMC/Radiochemistry to document process knowledge for manufacturing.
• Benchmark technologies and equipment to drive improvements.
• Support creation of lifecycle documents and SOP revisions.
• Maintain processes at continuous inspection readiness.
• Provide front-line technical support to manufacturing and ensure safe, compliant batch execution.
• Coordinate CAPA and deviations with cross-functional teams to ensure timely disposition.
• Perform data analysis to identify process shifts and trends for management escalation.
• Participate in process characterization and feasibility trials for robustness.

Skills

Deviation management

Root cause analysis

CAPA authorship

Change control

Education

Bachelor's degree in Chemical Engineering, Chemistry, Life Sciences

Tools

Qualio

Job description

Mariana Oncology is seeking an experienced MS&T Process Specialist to join our Manufacturing Science and Technology organization in the U.S. This role acts as the SME for assigned processes, owning deep process knowledge from clinical through commercial production and coordinating with CMC/Radiochemistry to ensure robust manufacturing.

The ideal candidate has a track record in deviation management, root cause analysis, CAPA authorship, and change control in a cGMP environment, with experience