Senior Data Scientist, CMC

Description

The company is a clinical-stage biopharmaceutical firm that develops treatments for central nervous system disorders, starting from genetic insights.

This role sits within CMC and supports drug substance and drug product processes, plus the packaging and labeling that get medicines to patients quickly and correctly the first time.

You will work with engineering, process chemistry, formulation, analytical development, quality, data science, and external CDMOs on small molecule and oligonucleotide programs, turning process and experimental data into insight for phase-appropriate choices.

The role suits a data scientist or process engineer who enjoys open-ended problems and wants real ownership. It blends process knowledge with data science and AI to shorten technology transfer, deepen process understanding, and make CMC data FAIR, traceable, and reusable.

Responsibilities

• Lead the development, validation, and deployment of mechanistic, hybrid, and data-driven models for drug substance, drug product, packaging, labeling, technology transfer, and manufacturing.
• Work with technical teams and CDMOs to convert DoE, PAT, IPC, batch record, and other process data into predictive models and analytics that guide process understanding, control strategy, risk assessment, and phase-appropriate decisions.
• Build fit-for-purpose analytics for drug product unit operations such as blending, granulation, compression, coating, and fill/finish, plus packaging and labeling, covering yield, throughput, readiness, and supply-chain scenarios.
• Create and maintain pipelines and FAIR data products that combine internal and CRO/CDMO data into traceable, reusable datasets in Databricks and related platforms. Build dashboards that make process performance, campaign comparisons, and technology-transfer readiness clear to technical and executive audiences.
• Act as digital product owner for process modeling and technology-transfer analytics. Set priorities, drive adoption, and apply AI and ML, including agentic workflows and LLM-based tools, to speed up CMC data review, knowledge capture, and routine analytical work under suitable validation and data-integrity controls.
• Use forecasting, scenario analysis, and cost-benefit analysis to improve right-first-time execution and shorten technology-transfer timelines. Present recommendations to stakeholders, help shape CMC data science strategy and regulatory filings, and mentor colleagues in data science and modeling.

Requirements

• Master's degree in chemical engineering, pharmaceutical sciences, data science, or a related scientific or engineering field, with proven use of data science in process development. A Bachelor's degree with equivalent experience will be considered.
• 5+ years of relevant experience in biotech or pharma process development, process engineering, or data science, ideally supporting drug substance or drug product development or technology transfer.
• Hands-on experience with process modeling, DoE, statistical analysis, and data-driven decision-making.
• Strong hands-on skill in Python and SQL, plus experience with Databricks or comparable data platforms and BI tools such as Power BI, Tableau, or Spotfire.
• Working knowledge of cGMP, ALCOA+, CMC regulatory expectations, and GxP-validated computerized systems.
• Ability to solve ambiguous problems, communicate complex ideas clearly, work independently, and build trusted relationships across functions.
• Intellectual curiosity, creativity, organization, attention to detail, and a strong drive for high-quality results. Comfortable in an agile, entrepreneurial setting and willing to both teach and learn.
• Optional: packaging and labeling operations experience is a plus.
• Optional: experience developing AI/ML applications and integrating AI-enabled tools into scientific or business workflows is preferred.
• Optional: experience supporting regulatory filings is a plus.
• Optional: experience working with CDMOs or CROs, external data flows, Agile ways of working, digital product ownership, or change management is preferred.

Conditions

The role may be performed remotely, but it requires flexibility and a willingness to travel as needed.

The annualized base salary range is $150,000 - $170,000 USD. Placement within the range depends on job-related factors, including experience, qualifications, scope of responsibilities, and a track record of delivering results in similar roles.

The job involves regular computer and device use, clear communication, occasional movement, screen work, basic hand coordination, and sustained focus. Reasonable accommodations may be made for individuals with disabilities.

Benefits

• The company pays 99% of the premium for medical, dental, and vision plans.
• Company-paid life insurance, AD&D, and disability benefits, plus voluntary plans to tailor your coverage.
• 401(k) with a dollar-for-dollar match up to 6% of eligible contributions.
• Long-term stock incentives and an employee stock purchase plan (ESPP).
• Discretionary quarterly bonus.
• A flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.