MSAT Lifecycle Management Data & Process Specialist

Position: MSAT Lifecycle Management Data & Process Specialist
Location: Boston, MA Hybrid (2 3 days onsite)
Duration: 2+ Years

Job Summary:
This role supports the management, validation, and delivery of commercial manufacturing data across the product lifecycle. The specialist will work with MSAT and cross-functional teams to maintain data integrity, support regulated lifecycle management activities, and execute established data processes accurately.

Key Responsibilities:

• Enter, review, verify, and approve manufacturing data from global internal and external manufacturing networks using validated databases.
• Prepare validated datasets and manufacturing process information for regulatory submissions, agency responses, technical studies, and cross-functional requests.
• Support Continuous Process Verification (CPV) and Annual Product Quality Review (APQR) reporting.
• Perform Data Verification (DV) for regulatory submissions, agency requests, and technical documentation.
• Maintain data in compliance with GMP/cGMP, data integrity standards, procedures, and internal controls.
• Review manufacturing data for trends, discrepancies, OOT, and OOS results.
• Support process trending, technical investigations, CPV activities, and cross-functional data reviews.
• Generate metrics, summaries, and reports for compliance and process monitoring.
• Utilize Microsoft applications, data systems, Power BI, and workflow/automation tools.
• Support digital improvement initiatives and perform structured data activities with a high level of accuracy.

Qualifications:

• Bachelor's degree in Life Sciences, Biochemistry, Process Chemistry, Manufacturing, MSAT, or a related scientific discipline.
• Engineering degrees with a Life Sciences concentration may also be considered.
• 2 years of relevant professional, internship, co-op, or industry experience.
• Recent graduates with relevant academic experience may be considered.
• Exposure to GMP or other regulated environments.
• Experience with data entry, verification, management, analysis, or reporting.
• General understanding of statistics and scientific, technical, or manufacturing data.
• Strong attention to detail, organization, communication, and ability to follow established procedures.
• Comfortable working with Microsoft applications and learning new digital systems.
• Basic knowledge of Python, SQL, C++, or similar programming languages is a plus.