MS&T Process Specialist

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CMC - Tech Ops - Watertown, Massachusetts

Reporting:

Director, Manufacturing Science & Technology

Description:

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.

Illustrative Breadth of Responsibilities:

Process Stewardship:

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.

Shop Floor Support:

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.

Deviations, Investigations, and CAPAs:

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.

Process Characterization and Manufacturing Excellence:

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.

Equipment and Qualification Support:

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.

Technology Transfer:

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.

Training:

Develop and deliver technical training to manufacturing personnel, including immediate-response training following deviation events and structured training for new products, processes, or procedures.

Own and maintain the training curriculum associated with this role and provide targeted support to new associates onboarding into the MS&T function.

Audit and Inspection Readiness:

Maintain all assigned processes and documentation at continuous inspection readiness, including SOPs, investigation records, and qualification documentation.

Provide direct support during internal and external audits and health authority inspections, including authoring responses and presenting process knowledge.

Requirements/Skills:

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

Minimum of 3 years of relevant experience in pharmaceutical manufacturing, MS&T, or a directly related function in a cGMP environment.

Prior experience in radiopharmaceuticals, sterile injectables, or small-volume parenteral manufacturing is strongly preferred.

Experience in process development, process engineering, or technical design, including exposure to radiochemistry, CMC activities, or pharmaceutical development workflows, is a plus and will be valued alongside a strong manufacturing or MS&T background.

Demonstrated expertise in deviation management, root cause analysis, CAPA authorship, and change control.

Working knowledge of GMP regulations including FDA 21 CFR Parts 210 and 211, ICH guidelines, and relevant pharmacopeial standards.

Experience supporting technology transfer activities from development into GMP manufacturing, including CDMO or CMO interfaces.

Proficiency with electronic quality management systems. Experience with Qualio or comparable QMS platforms is a plus.

Strong technical writing skills and the ability to produce clear, well-structured documentation under time pressure.

Excellent interpersonal and communication skills with demonstrated ability to work effectively across functional boundaries.

Mariana Oncology’s Principles

Building a Legacy

Execution Excellence

Courage of our Convictions

Mariana Oncology Compensation Summary:

The salary for this position is expected to range between $73,500 and $136,500 per year. Your compensation will also include a performance-based cash incentive.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and will be reviewed periodically upon joining Mariana Oncology. Mariana may change the published salary range based on company and market factors.

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Link to This Job

Location

Watertown, Massachusetts

Department

CMC - Tech Ops

Employment Type

Full-Time

Minimum Experience

Experienced

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