Director, Potency Assay Development- Analytical Operations
US - CA - Santa Monica, United States
USD 205K-266K Executive-level Full Time
Tasks
- Define potency assay control strategy using QbD and risk principles
- Drive potency assay development optimization and qualification
- Ensure assay robustness reproducibility and transferability
- Lead method transfer and external collaboration with QC and vendor labs
- Lead potency assay development team
- Manage CMC analytical projects for potency assays
- Oversee method validation verification documentation and SOPs
- Provide potency assay troubleshooting and data interpretation
- Support routine GMP release and stability testing
- Translate ICH guidance into compliant analytical strategies
Perks/Benefits
Skills/Tech-stack
By Design | CAPA | CAR-T | CGMP | Cell therapy | Change Control | Comparability | Control strategy | Cytokine release assays | Cytotoxicity assays | Data Integrity | Digital PCR | Dose response | Dose-response analysis | FCS Express | Flow Cytometry | FlowJo | Gene Therapy | ICH Guidelines | Infectivity assays | Method validation | Method verification | OMIQ | Parallel line analysis | Potency assays | Qualification | Quality by Design | Response analysis | Risk Assessment | Statistical Analysis | System suitability | System trending | Viral Vector
Education
Regions
Countries
States
Cities
Related jobs
-
Analytical Data | Analytical Data Review | Assay Performance Evaluation | CGMP | Cause analysisTravel opportunitiesSenior-level Full TimeUS - New Haven - CT, …21h ago
-
Associate Director, Computational Biology USD 180K-240KAgent-based | Agent-based modeling | Bioinformatics Databases | Cell biology | D3JS401k | Dental insurance | ESPP | Employee wellness | Medical insuranceMid-level Full TimeSilver Spring, MD, United States21h ago
-
Director of Quantitative Insights USD 158K-218KData Analysis | Data Integrity | Market Research | Measurement frameworks | Mixed methods401k matching | Dental insurance | Flexible working arrangements | Life insurance | Medical insuranceExecutive-level Full TimeWashington DC, United States21h ago
-
Senior Manager, Analytics USD 140K-160KAnalytics | Artificial Intelligence | Automation | Customer Data | Data AnalysisDental coverage | Employee discounts | Employee equity | Medical coverage | Pet insuranceSenior-level Full TimeRemote - United States R1d ago
-
Director of Enrollment Reporting & Analytics USD 83K-120KBanner | Data Analysis | Data Querying | Data Transformation | Data VisualizationFlexible spending accounts | Retirement plans | Tuition assistance | Tuition discountsExecutive-level Full TimeWhite Corners, United States1d ago
-
Actuator integration | Adhesive Bonding | Assembly automation | Automation control | CQVSenior-level Full TimeUS: Indianapolis IN Tech Center North, …1d ago
-
Director, Finance Analytics & Reporting USD 160K-213KAccess Management | Analytics | Business Intelligence | Change Management | Data Modeling401k matching | Dental insurance | Employee stock purchase program | Flexible time off | Health insuranceExecutive-level Full TimeUSA Remote, United States R1d ago
-
Director, Epidemiology & RWE Analytics USD 202K-275KClinical Trial Design | Clinical trial | Data Analysis | Endpoint validation | EpidemiologyCaregiver leave | Health insurance | Medical leave | Paid Holidays | Paid personal daysExecutive-level Full TimeUS CA San Diego, United States1d ago
-
Access Analytics | Alteryx | Call planning | Claims data | Commercial Model Design401k | Bonus | Collaborative culture | Restricted stock units | Training programsSenior-level Full TimeBoston, Massachusetts2d ago
-
Associate Director, Marketing Analytics - Rheumatology USD 137K-261KData Modeling | Forecasting | KPI Development | Machine Learning | Marketing Mix401k | Dental insurance | Long-term incentive programs | Medical insurance | Paid time offMid-level Full TimeMettawa, IL, United States4d ago
-
Director, Revenue Analytics USD 151K-189KBigQuery | Business Intelligence | Data Warehousing | Excel | ForecastingCareer development opportunities | Coaching opportunities | Health and welfare benefits | Hybrid work model | Paid time offExecutive-level Full TimeWaltham or Boston, MA4d ago
-
Assistant Director of Enrollment, China USD 62K-68KAdmissions Process | Appointment Scheduling | Customer relations | Data Integrity | Financial AidExecutive-level Full TimeAtlanta4d ago
-
A/B | A/B Testing | Agentic AI | Agile | B testingBackup childcare | Financial coaching | Health care coverage | Mental health support | On-site health and wellness centersExecutive-level Full TimeWilmington, DE, United States4d ago
-
Director, Decision Science Analytics - Finance Analytics USD 164K-314KBusiness Intelligence | Business Objects | Cloud ERP | Data Engineering | Data Visualization401 K | Adoption Assistance | Career path planning | Comprehensive medical, dental and vision plans | Continuing educationExecutive-level Full TimeSan Antonio Home Office I, United …4d ago
-
Biostatistics | Clinical Trial Data | Clinical trial | Comparative Effectiveness | Confounding401k savings plan | Paid time off | Parental leave | Retirement plan pensionExecutive-level Full TimeUS159 NJ Titusville - 1125 Trenton-Harbourton …4d ago
-
Head of Consumer Bank Data Analytics, CX and Research USD 214K-252KArtificial Intelligence | Azure | Behavioral analytics | CSAT | Customer Experience401k | Adoption Assistance | Dental | Healthcare | Life insuranceExecutive-level Full TimeMinneapolis, MN, United States4d ago
-
Director, National Quality Analytics & Performance Improvement - HEDIS Reporting/Databricks/Power BI - Remote USD 135K-208KAWS | Azure | Data Modeling | Forecasting | HadoopExecutive-level Full TimeUnited States R5d ago
-
Sr. Director, Reporting & Analytics - Patient Services USD 143K-190KAcceptance criteria | Cause analysis | Cloud Storage | Data Requirements | Data ScienceExecutive-level Full TimeMason, OH, United States5d ago
-
Director, Data Engineering USD 240K-314KAI tool integration | Agent Orchestration | Agentic Systems | Analytics | Bias MitigationExecutive-level Full TimeMenlo Park, CA5d ago
-
Director, Global Data and Analytics USD 85K-200KAPI | Alteryx | BigQuery | Data Visualization | Data pipeline401k matching | Company holidays | Fertility coverage | Flexible paid time off | Medical, dental, and vision coverageExecutive-level Full TimeUSA-NY 1755 Broadway, United States5d ago
-
Director, Biostatistics Hematology USD 216K-262KBiostatistics | Clinical Development | Clinical Development Plans | Clinical Practice | Clinical Trial Methodology401k plan | Employee assistance program | Health coverage | Life insurance | Paid time offExecutive-level Full TimeBerkeley Heights - NJ, United States5d ago
-
Access Governance | Change Management | Dashboards | Data Governance | Data IntegrityCommuter benefits | Dental | Employee assistance program | Healthcare spending account | Income protectionExecutive-level Full TimeDallas, Texas, United States; Oklahoma City, … R5d ago
-
Director – Health AI and Data Science USD 226K-376KAnalytics | Artificial Intelligence | Cloud Data | Cloud Data Platforms | Data Engineering401k retirement plan | Emergency back-up childcare program | Employee referral program | Flexible spending accounts | Health savings accountExecutive-level Full TimeGH Office: Tysons Corner, VA (Headquarters), …5d ago
-
Associate Director, Analytics - Immunology Pipeline USD 137K-261KAnalytics | Competitive Intelligence | Data Modeling | Data analytics | Forecasting401k | Dental insurance | Health insurance | Long-term incentive program | Paid time offMid-level Full TimeMettawa, IL, United States6d ago
-
Business Intelligence | Data Analysis | Data Integrity | Excel | SQLRemote work | Travel as neededExecutive-level Full TimeTampa, FL R7d ago