Senior Data Scientist, CMC

About the role

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is seeking a Senior Data Scientist to build and deploy the models, data products, and digital tools that help us develop drug substance and drug product processes, as well as the packaging and labeling that gets them to patients quickly and correctly the first time.

Working within CMC alongside Engineering, Process Chemistry, Formulation, Analytical Development, Quality, Data Science, and external CDMOs, you will turn process and experimental data into actionable insight and phase-appropriate decisions across small molecule and oligonucleotide programs.

This is a hands-on, high-ownership role for a data scientist or process engineer who thrives on open-ended problems. You will combine process knowledge with modern data science and AI to improve technology transfer timelines, strengthen process understanding, and make CMC data FAIR, traceable, and reusable across the organization.

Primary Responsibilities

• Build and deploy models: Lead the development, validation, and deployment of mechanistic, hybrid, and data-driven models supporting drug substance, drug product, packaging, and labeling processes, technology transfer, and manufacturing.
• Turn CMC data into decisions - Partner with technical teams and CDMOs to translate DoE, PAT, IPC, batch record, and other process data into predictive models and analytics that inform process understanding, control strategy, risk assessment, and phase-appropriate decisions.
• Develop fit-for-purpose analytics: Build analytics for drug product unit operations such as blending, granulation, compression, coating, and fill/finish, as well as packaging and labeling operations, including yield, throughput, readiness, and supply-chain scenario analysis.
• Build reusable data products: Develop and maintain pipelines and FAIR data products that integrate internal and CRO/CDMO data into traceable, reusable datasets within Databricks and related platforms. Develop dashboards and visualizations that make process performance, campaign comparisons, and technology-transfer readiness clear to technical and executive audiences.
• Apply AI and own the digital roadmap: Serve as digital product owner for process modeling and technology-transfer analytics, defining priorities, driving adoption, and applying AI/ML-including agentic workflows and LLM-based tools-to accelerate CMC data review, knowledge capture, and routine analytical work with appropriate validation and data-integrity controls.
• Drive impact and enable teams: Use forecasting, scenario analysis, and cost-benefit analysis to improve right-first-time execution and shorten technology-transfer timelines. Present recommendations to stakeholders, contribute to CMC data science strategy and regulatory filings, and mentor colleagues in data science and modeling practices.

Qualifications and Key Success Factors

• Master's degree in Chemical Engineering, Pharmaceutical Sciences, Data Science, or a related scientific or engineering field, with demonstrated application of data science to process development; Bachelor's degree with equivalent experience will be considered.
• 5+ years of relevant experience in biotech/pharma process development, process engineering, or data science, ideally supporting drug substance and/or drug product development or technology transfer.
• Experience with process modeling, DoE, statistical analysis, and data-driven decision-making; exposure to packaging and labeling operations is a plus.
• Strong hands-on skills in Python and SQL, with experience using Databricks or comparable data platforms and BI/visualization tools such as Power BI, Tableau, or Spotfire.
• Experience developing AI/ML applications and integrating AI-enabled tools into scientific or business workflows preferred.
• Working knowledge of cGMP, ALCOA+, CMC regulatory expectations, and GxP-validated computerized systems; experience supporting regulatory filings is a plus.
• Experience working with CDMOs/CROs, external data flows, Agile ways of working, digital product ownership, or change management preferred.
• Demonstrated ability to solve ambiguous problems, communicate complex ideas clearly, work with self-direction, and build trusted relationships across functions.
• Brings intellectual curiosity, creativity, innovation, organization, attention to detail, and a strong bias toward high-quality results. Thrives in an agile, entrepreneurial environment and is willing to both teach and learn.

Additional information

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus.

Compensation & Benefits

• At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.
• This includes 99% of the premium paid for medical, dental and vision plans.
• We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• Thinking about the future?

• We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.
• We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.
• Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.
• We aim high, collaborate hard, and produce results.

Let's achieve the impossible together!

To round out our world-class total rewards package, we provide annualized base salary in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Annualized Base Salary $150,000—$170,000 USD

Diversity, Equity & Inclusion

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