Mariana Oncology
Reporting:
Director, Manufacturing Science & Technology
Description:
We are seeking an experienced Associate Director, MS&T Compliance to join Mariana's Manufacturing Science & Technology organization, advancing personalized medicine and radiopharmaceuticals. This role will provide leadership in compliance for manufacturing activities, with a strong focus on deviation investigations, change management, root cause analysis, and inspection readiness. The Associate Director will serve as a subject matter expert in cGMP manufacturing compliance, ensuring operational excellence, continuous improvement, and alignment with regulatory expectations in the radiopharmaceutical sector. This position will also manage compliance-related projects and act as the primary MS&T representative in interactions with Quality functions.
Illustrative Breadth of Responsibilities:
Lead and oversee investigation activities for deviations, including coordination of cross-functional teams and impact assessments. Develop and author change controls, deviation reports, root cause analyses, corrective and preventive action (CAPA) plans, and other compliance documentation. Drive the timely closure of investigations, CAPAs, and change controls in close collaboration with Quality and MS&T leadership. Manage ongoing MS&T compliance projects to ensure alignment with quality and regulatory requirements, while driving continuous improvement initiatives. Deliver training to MS&T, Manufacturing, and Support teams on investigation best practices, root cause analysis, and CAPA effectiveness. Provide inspection readiness support for both personnel (training, responses, mock inspections) and facilities (equipment, documentation, and cleanliness). Identify compliance risks within GMP manufacturing operations and recommend process improvements aligned with Right-First-Time principles. Support and execute risk assessments, gap analyses, and compliance-focused operational reviews. Serve as the MS&T compliance representative during audits, inspections, and management review presentations. Act as the key liaison between MS&T and local/parent company Quality Assurance functions, ensuring alignment on compliance priorities, strategies, and execution. Partner with cross-functional teams to strengthen operational and regulatory compliance across MS&T activities. Other duties as assigned. Requirements/Skills:
Bachelor's degree in Life Sciences, Engineering, or related field; advanced degree preferred. 8+ years of experience in MS&T, Process Development, or Manufacturing within the pharmaceutical, biotechnology, or radiopharmaceutical industry. Strong expertise in deviation management, CAPA systems, change control processes, and GMP compliance frameworks. Working knowledge of bioprocessing workflows including upstream, downstream, and analytical operations. Demonstrated ability to analyze complex technical data and drive data-based decision-making. Strong scientific and engineering aptitude with proven problem-solving and compliance investigation skills. Excellent written and verbal communication, including the ability to present to auditors, inspectors, and senior leadership. Proven track record in training and developing technical staff in compliance and investigation best practices. Experience with electronic quality management systems (e.g., Veeva), ERP platforms, and statistical tools (e.g., JMP, SIMCA) strongly preferred. In-depth understanding of regulatory requirements (FDA, EMA, ICH) in a GMP manufacturing environment. Mariana Oncology's Principles
Building a Legacy Execution Excellence Courage of our Convictions
Director, Manufacturing Science & Technology
Description:
We are seeking an experienced Associate Director, MS&T Compliance to join Mariana's Manufacturing Science & Technology organization, advancing personalized medicine and radiopharmaceuticals. This role will provide leadership in compliance for manufacturing activities, with a strong focus on deviation investigations, change management, root cause analysis, and inspection readiness. The Associate Director will serve as a subject matter expert in cGMP manufacturing compliance, ensuring operational excellence, continuous improvement, and alignment with regulatory expectations in the radiopharmaceutical sector. This position will also manage compliance-related projects and act as the primary MS&T representative in interactions with Quality functions.
Illustrative Breadth of Responsibilities:
Lead and oversee investigation activities for deviations, including coordination of cross-functional teams and impact assessments. Develop and author change controls, deviation reports, root cause analyses, corrective and preventive action (CAPA) plans, and other compliance documentation. Drive the timely closure of investigations, CAPAs, and change controls in close collaboration with Quality and MS&T leadership. Manage ongoing MS&T compliance projects to ensure alignment with quality and regulatory requirements, while driving continuous improvement initiatives. Deliver training to MS&T, Manufacturing, and Support teams on investigation best practices, root cause analysis, and CAPA effectiveness. Provide inspection readiness support for both personnel (training, responses, mock inspections) and facilities (equipment, documentation, and cleanliness). Identify compliance risks within GMP manufacturing operations and recommend process improvements aligned with Right-First-Time principles. Support and execute risk assessments, gap analyses, and compliance-focused operational reviews. Serve as the MS&T compliance representative during audits, inspections, and management review presentations. Act as the key liaison between MS&T and local/parent company Quality Assurance functions, ensuring alignment on compliance priorities, strategies, and execution. Partner with cross-functional teams to strengthen operational and regulatory compliance across MS&T activities. Other duties as assigned. Requirements/Skills:
Bachelor's degree in Life Sciences, Engineering, or related field; advanced degree preferred. 8+ years of experience in MS&T, Process Development, or Manufacturing within the pharmaceutical, biotechnology, or radiopharmaceutical industry. Strong expertise in deviation management, CAPA systems, change control processes, and GMP compliance frameworks. Working knowledge of bioprocessing workflows including upstream, downstream, and analytical operations. Demonstrated ability to analyze complex technical data and drive data-based decision-making. Strong scientific and engineering aptitude with proven problem-solving and compliance investigation skills. Excellent written and verbal communication, including the ability to present to auditors, inspectors, and senior leadership. Proven track record in training and developing technical staff in compliance and investigation best practices. Experience with electronic quality management systems (e.g., Veeva), ERP platforms, and statistical tools (e.g., JMP, SIMCA) strongly preferred. In-depth understanding of regulatory requirements (FDA, EMA, ICH) in a GMP manufacturing environment. Mariana Oncology's Principles
Building a Legacy Execution Excellence Courage of our Convictions