Associate Director, Process Data Analytics

Our Opportunity...

We are looking for a highly motivated, collaborative, sophisticated data scientist for our Associate Director of Process Data Analytics role, with strong CMC domain expertise and advanced statistical modeling experience. As a key contributor within our Process Development and MSAT team, this hands-on and strategic leader will define and deliver advanced analytics, statistical modeling, and fit for purpose data infrastructure for real time monitoring of cell and gene therapy manufacturing processes, helping to drive the late-stage development of our first clinical stage autologous cell therapy program targeting solid tumors. 

You’ll translate multi-dimensional process and product datasets into actionable insights that deepen understanding, inform CMC decision making, support regulatory submissions, and strengthen data driven execution. Partnering cross-functionally and with external partners, you’ll ensure data integrity and drive the compliant integration of AI/ML tools to accelerate manufacturing intelligence 

As a member of our Process Development and MSAT team, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE® platform. This is a unique opportunity to be a valuable contributor in a well-funded clinical company with field-leading advisors, best-in-class partners, and an experienced team.     

You Will...

Core responsibilities

• Deliver sophisticated statistical modeling, process monitoring, and visualization of datasets across manufacturing lines.   
• Synthesize complex technical data for cross-functional governance and leadership forums, and partner with Process Development, Analytical Development, Quality Control, Quality Assurance, CMOs, CMC teams, executive leadership, to translate into operational and regulatory insights.  
• Establish data infrastructure to seamlessly collect, clean, store, and analyze manufacturing and quality data across both paper and electronic sources including Electronic Batch Records (EBR), Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and Supervisory Control and Data Acquisition(SCADA), and related systems.  
• Act as the primary business owner for technical databases, ensuring cross-functional alignment between Process Development, Quality Assurance, and Contract Manufacturing Organizations (CMOs).  
• Build and manage interactive dashboards using platforms like Tableau, Power BI, or Spotfire to deliver real-time process monitoring to executive leadership and CMC team.  
• Author and review CMC technical documentation, data trending summaries, process validation protocols, and other input to CMC regulatory sections for BLA/MAA submissions.  
• Lead the establishment of the process monitoring program by applying statistical process control methodologies (SPC). Provide insights for establishment of in-process control ranges, and statistical justification for release attributes.  
• Deploy advanced statistical methodologies to monitor process parameters (CPPs) and critical quality attributes (CQAs).  
• Support PPQ readiness, process characterization, tech transfer, process monitoring, root-cause investigations, impact assessments for complex manufacturing deviations, atypical events, and out-of-trend data.  
• Establish GMP Process Data Analytics Tool to enable Stage 3 of Process Validation (prior to BLA) and Analytical Product Review evaluations and reports.  
• Support design of comparability statistical approach.  
• Partner with CDMOs and CTLs, and lead a small, fit for purpose, high performing team of internal and external resources and SMEs. 

You Bring...

Core Qualifications

• PhD or MS in Statistics, Biostatistics, Bioinformatics, Data Science, or a closely related quantitative discipline.  
• 10+ years of progressive experience in biopharma, including 5+ in process data analytics supporting late-stage drug development and activities relevant to clinical or commercial manufacturing.  
• Hands-on experience designing, building, validating, documenting, and deploying data infrastructure (including storage, pipelines, and relational data systems), analytical models, and data products in a manner appropriate for regulated or quality-sensitive environments.   
• Experience generating and reviewing content for CMC regulatory submissions.  
• Proficiency in Python, SQL, and SAS for statistical analysis, data visualization, process monitoring, and data-driven decision making  
• Expertise with statistical software including SIMCA (Soft Independent Modeling of Class Analogy), JMP, and Minitab.   
• Strong knowledge of generative AI tools and modern data science frameworks (e.g., pandas, NumPy, scikit-learn, Power BI, and XGBoost) to support advanced analytics, predictive modeling, automated reporting, and data-driven decision-making  
• Strong written and verbal communication skills, including the ability to translate complex analyses into clear recommendations for program leaders and non-statistical stakeholders.  
• Excellent planning organization and documentation skills, with the ability to manage multiple priorities while maintaining data integrity, traceability, and high-quality records.  
• Proven ability to partner with internal SMEs (including Digital Systems & Technology), external vendors (CDMOs/CROs), and lead cross-functional technical teams.  
• Flexibility and self-motivation, with the ability to adapt to shifting priorities and operate effectively with general direction in a fast-paced environment. 
• Collaborative and accountable – recognizes success requires interdisciplinary thinking and teamwork; shares feedback and ideas, productively challenges own and others’ assumptions to facilitate better outcomes  
• Self-motivated, with a proven ability to work with general direction to meet objectives and timelines, managing multiple responsibilities in parallel.    
• Flexible - adapts to change in a fast paced, rapidly developing environment  
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner  
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments 
• Operates with urgency, adept at building buy-in and driving alignment within and across teams, senior leadership, and external partners.   
• Seeks the data, information, and support needed (internally and externally) to make efficient and informed decisions and meet objectives.    
• Continuous learner – actively follows innovations in area of expertise, fosters innovative thinking, and adopts novel approaches that are fit for purpose.  
• Reflective and self-aware.  

Bonus Qualifications

• Exposure to cell therapy workflows (e.g., CAR-T, TCR, NK cells), live cell process dynamics, and biologic regulatory guidelines (ICH-GCP, FDA).