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Role Description

This position is responsible for maintaining product static data within Laboratory Information Management Systems (LIMS) and collaborating with IT and Quality to enhance system functionality. This role involves applying advanced statistical techniques to developing real-time monitoring dashboards and support continuous improvement initiatives. The incumbent will contribute to investigations, process change assessments, and regulatory documentation through data mining, statistical analysis, and visualization. They will champion innovation by leveraging emerging technologies and methodologies from the data science community.

• Maintain product static data within Laboratory Information Management Systems (LIMS) and collaborate with IT to enhance system functionalities.
• Advance the application of statistical techniques, such as multivariate analysis and statistical process control, to support continuous improvement initiatives.
• Build real-time monitoring tools for batch release and stability data using platforms such as JMP, R, Python, and MATLAB.
• Build predictive models and conduct large-scale data analyses to enable proactive, data-driven decision-making across operations.
• Champion innovation by leveraging best-in-class data and technology from the data science community to identify emerging opportunities and capabilities that can be implemented within the organization.
• Support analytical release and stability testing of drug substance and drug product material at contract testing laboratories.
• Assist in authoring, reviewing, and maintaining internal and external quality documents to ensure compliance with regulatory standards.
• Provide support for regulatory filings by preparing, reviewing, or contributing analytical data summaries, reports, and supporting documentation for submissions.

Qualifications

• Bachelor’s or advanced degree in Data Science, Statistics, or Sciences.
• Associate Minimum 0 - 3 years of relevant experience in biotech or pharmaceutical industry.
• A background or experience in analytical sciences is a plus.

Requirements

• Strong foundation in statistical analysis, data visualization, and data management to support analytical and operational decision-making.
• Familiarity with tools such as JMP, MATLAB, Minitab, R, or Python for developing predictive models, conducting multivariate analysis, and implementing statistical process control.
• Familiarity with data architecture principles.
• Strong communication skills for translating complex analytical findings into clear, actionable insights for both technical and non-technical stakeholders.
• Ability to collaborate across cross-functional teams, manage multiple priorities, and maintain a high level of attention to detail.
• Skilled at identifying potential opportunities and applying detail-oriented solutions to achieve impactful outcomes.
• Organized and strategic, with the ability to balance detailed execution and big-picture thinking.

Benefits

• Base salary range for this role is $77,300 to $96,000.
• Opportunity for merit-based salary increases.
• Short incentive plan participation.
• Eligibility for 401(k) plan.
• Medical, dental, vision, life and disability insurances.
• Flexible paid time off.
• 11 paid holidays plus additional time off for a shut-down period during the last week of December.
• 80 hours of paid sick time upon hire and each year thereafter.