MSAT Lifecycle Data & AI Specialist

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 44,000 - 74,000; Full time

Job summary

Vertex Pharmaceuticals seeks an MSAT Lifecycle Management Data & Process Specialist to oversee completeness, validation, and delivery of commercial manufacturing data throughout the product lifecycle. The role partners with Regulatory, QA, and cross-functional teams to support submissions, investigations, and data-driven decision making.

Responsibilities include data stewardship, CPV/APQR support, DV protocol execution, and adoption of AI-driven workflows to improve data integrity and process

Qualifications

• Bechlor's degree in Life Sciences (or engineering with life sciences concentration) with 0–2 years of relevant experience.
• Direct experience managing, preparing, and verifying data for technical regulatory/agency reports and questions.
• Demonstrated hands-on experience utilizing generative AI technologies to streamline or automate internal processes.
• Strong background working with data management software configurations spanning data collection, preparation, storage, analysis, and visualization.
• Basic knowledge of programming or coding using Python, SQL, C++, or a similar programming language
• General understanding of statistical concepts and experience interpreting or analyzing data.

Responsibilities

• Enter and approve manufacturing data into internal validated databases.
• Provide validated data packages for regulatory submissions and responses.
• Support CPV deliverables and APQR reporting by managing global site data entry and completeness.
• Execute and sign off on Data Verification protocols for regulatory submissions.
• Ensure data handling complies with CGT, cGMP, data integrity, and internal controls.
• Analyze complex manufacturing datasets to identify OOT and OOS anomalies.
• Collaborate with MSAT groups on trend investigations and CPV-related events.
• Participate in cross-functional data review forums to monitor metrics and mitigate risks.
• Synthesize technical data, resolve data issues, and generate metrics for decisions.
• Provide training on data systems and practices.

Skills

Generative AI technologies

Python/SQL/C++ knowledge

Data management software

Data analysis

Cross-functional collaboration

Regulatory data management

cGMP knowledge

Education

Bachelor's degree in Life Sciences (or engineering with life sciences concentration)

Tools

Data management software configurations

Job description

Vertex Pharmaceuticals seeks an MSAT Lifecycle Management Data & Process Specialist to oversee completeness, validation, and delivery of commercial manufacturing data throughout the product lifecycle. The role partners with Regulatory, QA, and cross-functional teams to support submissions, investigations, and data-driven decision making.

Responsibilities include data stewardship, CPV/APQR support, DV protocol execution, and adoption of AI-driven workflows to improve data integrity and process