Senior principal scientist data science and automation engineering
Job Description
Vertex MSAT team is seeking a Senior Principal Data Scientist to join a growing team in support of commercial Cell and Gene Therapy programs. This position will be responsible for leading and providing technical support in alignment with defined program priorities pertaining to data acquisition, analysis, trending, visualization, and reporting. Key Responsibilities- Identify and develop technical solutions to enable program and company goals.
- Lead development of data trending visualizations using Statistica and for process parameters
- Lead the Development of Routine Data Visualization charts and tools
- Develop scripts for automated reporting of trends and correlations
- Develop visualization for acknowledged alarm reporting and trending
- Author SOPs and work instructions to standardize the process of pulling trend reports from TIBCO.
- Author technical protocols, reports, and other GMP supporting documents.
- Contribute to developing technical solutions to enable program and company goals.
- Ability to work within a team and independently
- Provide regular (weekly) updates towards project goals.
- PhD, MS, or BS in relevant science or engineering discipline.
- PhD with 5+ years, MS with 7+ years, or BS with 9+ years of experience.
- Significant experience with data software packages including Statistica and Spotfire at a minimum.
- Experience with cell therapy or large-scale GMP manufacturing for biopharmaceutical manufacturing
- Experience with designing process monitoring tools to detect OOT/OOE
- Experience with designing process visualization tools to show process trends
- Experience with designing automated trend outputs
- Experience with process characterization and process control strategy preferred.
- Experience with cGMP regulations/guidance and with regulatory agency inspections preferred.
- Experience with inline process analytical technologies for assessment of manufacturing performance
- Experience working and leading projects in a matrixed organization
- Experience working with external partners (CMOs, vendors, etc.).
- Excellent communication skills, both written and verbal
- Ability to travel, nationally and internationally, up to 10 - 15%.
- Flexibility to work on site a minimum of 3 days per week.
- Hybrid: work remotely up to two days per week; or select
- On-Site: work five days per week on-site with ad hoc flexibility.
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