Job Description
Job DescriptionSalary:
Reporting:
Director, Manufacturing Science & Technology
Description:
We are seeking an experienced Associate Director, MS&T Compliance to join Marianas 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:
- Bachelors 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 Oncologys Principles
- Building a Legacy
- Execution Excellence
- Courage of our Convictions