MSAT Process Data Scientist
The MSAT Process Data Scientist is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to manufacturing of all Seagen products, whether manufactured internally or at contract manufacturing organizations (CMO’s). The MSAT Process Data Scientist will support process data input, capture and analysis for manufacturing operations, scientific investigation, validation and Continuous Process Verification. This Scientist supports MSAT investigations and trouble-shooting activities both internally and externally. The incumbent provides data, analytics and scientific support to the MSAT team. This role will report to Validation Director but will support and collaborate across the MSAT team.
- Provides data management and analytics expertise required to support MSAT and Seagen manufacturing, both internal and external across all product modalities.
- Conduct data analyses in support of MSAT responsibilities by leveraging a variety of analytics approaches to deliver data and information for investigations, trending, anomalies or deviations, root cause analyses, etc.
- Through collaboration with Manufacturing and Data Sciences ensure data is captured and entered into Discoverant enabling appropriate data analysis and trending.
- Provides data analysis and trends to support the Product Health Reviews, CMO and Partner requirements, investigations, validations etc.
- Assists and participates in scientific investigations and deviations. Drafts protocols, reports and completes deviation reports
- Collaborates with Data Science in drafting the annual and ad hoc CPV reports (is the MSAT lead on all CPV reporting)
- Assists with change control and batch record documentation
- Manages and updates the MSAT KPI dashboard
- Collaborates with Development, Manufacturing and Quality for data and knowledge sharing (site know-how transfers)
- Initiates and carries out process and procedural changes to improve MSAT data management, product robustness and compliance
- Scientific and technical experience within Pharmaceutical development or manufacturing.
- Knowledge of statistical analysis, validation and continuous process verification.
- Experience with manufacturing data management and analysis is desirable
- The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency.
- Motivated with the ability to work independently as well as on cross-functional and cross-site teams.
- Strong communication skills and computer literacy are essential
- Fluency in spoken and written English is mandatory
- Detail oriented, strong organization and time management skills
- Motivated and willing to learn and grow
- Creative problem solver willing to troubleshoot and establish new protocols
- Bachelor’s Degree in Chemistry, Biochemistry, Bioengineering, Chemical Engineering or related field with 4+ years experience of pharmaceutical development or manufacturing. Alternatively a Master’s or PHD with 2+ years experience