MS&T Process Specialist

MS&T Process Specialist

We are seeking an experienced MS&T Process Specialist to join Mariana's Manufacturing Science and Technology organization, advancing personalized medicine and radiopharmaceuticals. This role serves as the subject matter expert and technical steward for assigned pharmaceutical manufacturing processes, owning deep process knowledge from clinical through commercial production. The MS&T Process Specialist provides front-line technical support to manufacturing, drives process characterization and robustness programs, and acts as a critical interface between site operations, Quality, and CMC/Radiochemistry, working closely alongside radiochemistry and CMC colleagues to build shared process knowledge and ensure their continued, direct support of clinical manufacturing.

The ideal candidate brings demonstrated pharmaceutical manufacturing expertise, structured problem-solving skills, and a genuine commitment to operational excellence in a fast-paced clinical manufacturing environment.

• Act as the single point of contact and subject matter expert for assigned process technologies, including interfaces with external technical development organizations and the broader MS&T network.
• Own the process knowledge base for assigned technologies, including pilot scale, scale-up and scale-down activities, and Design of Experiments.
• Partner closely with CMC/Radiochemistry to develop and document process knowledge for assigned technologies, serving as a bridge between chemistry expertise and manufacturing execution rather than a replacement for direct CMC engagement with the production floor.
• Benchmark relevant process technologies and equipment internally and within the broader scientific and regulatory environment to expand organizational know-how and identify improvement opportunities.
• Support creation of all lifecycle documents for assigned process areas, including User Requirements Specifications, Functional Risk Assessments, and related technical records.
• Support creation and revision of SOPs within the assigned process area.
• Maintain assigned processes at continuous inspection readiness.

• Provide front-line technical and procedural support to manufacturing, working directly with the production team to ensure each batch is executed safely, on time, and in compliance with the batch record and quality requirements.
• Serve as an active manufacturing SME, providing the production team with current best practices, investigation findings, and CAPA status updates in real time.
• Perform routine and ad hoc data analysis to identify process shifts and trends, and escalate emerging signals to management as appropriate.

• Author investigations for product and non-product deviations, including Out of Expectation, Out of Specification, and Out of Tolerance results.
• Apply process knowledge and structured root cause analysis methodologies to identify the true causes of product and process failures.
• Coordinate cross-functionally with Scheduling, Quality, and Manufacturing to ensure timely batch disposition through robust investigations and documented impact assessments.
• Initiate CAPAs and conduct CAPA effectiveness checks to eliminate or mitigate recurrence of deviations.
• Prepare clear, complete escalation packages when appropriate, including root cause summaries and corrective action plans, and present to management on time.

• Perform process characterization activities for assigned technologies to increase robustness, sustainability, and clinical and commercial readiness.
• Design and execute technical feasibility trials related to process improvement and implementation of new manufacturing technologies.
• Collaborate with CMC/Radiochemistry and Quality to identify and drive process, operational, and quality improvements, facilitating the translation of chemistry and development insights into robust manufacturing outcomes.
• Evaluate manufacturing pre-production technical data, including incoming material review, to support timely and compliant batch pathway decisions.
• Provide management with timely updates on manufacturing performance and escalate potential issues proactively.
• Support Quality Risk Assessments for assigned process areas.

• Provide technical expertise to cross-functional personnel for design activities related to capital projects within the assigned area of responsibility.
• Support equipment qualification activities, including review and input to qualification protocols and reports, for technologies within the assigned scope.

• Serve as the process SME for assigned technology platforms following handover from development or launch into clinical or commercial production.
• Support incoming and outgoing process technology transfer activities, including execution of transfer protocols, generation of technical reports, and cross-site coordination with CDMOs and CMOs.
• Contribute to the preparation of technology transfer plans, gap assessments, and comparative process evaluations.

• Develop and deliver technical…