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
-
Business Intelligence | Data Modeling | Data Warehousing | Google Analytics | OKRExecutive-level Full TimeNew York, NY, USA; Atlanta, GA, …10h ago
-
PGIM - Director, People Analytics (Hybrid) USD 175K-215KAI tools | Anaplan | Data Frameworks | Data Quality | Data Science401k plan | Dental insurance | Disability insurance | Education benefit | Employee stock purchase planExecutive-level Full TimePrudential Tower, 655 Broad Street, Newark, … R21h ago
-
Director of Customer Analytics USD 149K-193KAPIs | Adobe Analytics | Alteryx | BigQuery | Churn PredictionExecutive-level Full TimeMiddletown, CT, 06457, US1d ago
-
Associate Director, International Market Analytics and Business Intelligence, Parkinson's USD 106K-202KBusiness Intelligence | Competitive Intelligence | Data Source | Data Source Discovery | Data analytics401k | Dental insurance | Holidays | Long-term incentive program | Medical insuranceEntry-level Full TimeMettawa, IL, United States1d ago
-
Associate Director, Market Access Analytics - Neurology USD 157K-256KData Mining | Data Storytelling | Data Visualization | Databricks | Dataiku401k company match | Annual bonuses | Equity awards | Family support benefits | Fitness centersMid-level Full TimeSLEEPY HOLLOW, United States1d ago
-
Interim Director of Analytics USD 123K-171KBig Data | Business Intelligence | Business Objects | Clinical EHR | Dashboarding401k retirement plan | Dental insurance | Health insurance | Life insurance | Paid time offSenior-level TemporaryDallas, Texas, United States1d ago
-
Director, Associate Experience Data & Analytics USD 45K-100KCohort Analysis | Dashboarding | Data Governance | Data Quality | Data VisualizationDental insurance | Hybrid work | Medical insurance | Paid time off | Parental leaveMid-level Full TimeFL - Saint Petersburg - 880 …1d ago
-
Director, Analytics USD 100K-120KAdobe Analytics | Attribution | Campaign Optimization | Data Visualization | Data reporting401k match | Cell phone reimbursement | Coaching and development program | Financial coaching | Flexible time offExecutive-level Full TimeUnited States R1d ago
-
Senior Director, Finance Data Governance and Management USD 196K-342KBP Customer Vendor Master Data | Company Codes | Cost Centers | Cost Control | DAMASenior-level Full TimeUS017 NJ New Brunswick - 1 …1d ago
-
Director, P&C Marketing Channel Analytics USD 164K-296KAttribution Modeling | Business Intelligence | Data Mining | Data Visualization | Data Wrangling401k | Adoption Assistance | Career path planning | Continuing education | Life insuranceExecutive-level Full TimeSan Antonio Home Office I, United …2d ago
-
Applied AI ML Director - AGENT BUILDER PLATFORM USD 140K-195KA/B | A/B Testing | API Design | AWS Bedrock | AWS SageMakerBackup childcare | Financial coaching | Health care coverage | Mental health support | On-site health and wellness centersExecutive-level Full TimePalo Alto, CA, United States5d ago
-
Director of AI Analytics USD 115K-200KAdvanced Analytics | Artificial Intelligence | Conversion Rate | Conversion rate optimization | Customer AnalyticsExecutive-level Full TimeRemote - US R5d ago
-
Director, Quantitative Clinical Pharmacologist USD 183K-305KClinical Study Design | Clinical pharmacodynamics | Clinical pharmacokinetics | Clinical study | Dose RecommendationHealth insurance | Paid Holidays | Paid caregiver leave | Paid medical leave | Retirement benefitsExecutive-level Full TimeUpper Providence, United States5d ago
-
Director of Graduate Enrollment Strategy USD 79K-110KAI tools | Artificial Intelligence | CRM Analytics | Campaign Management | CodaDental insurance | Health insurance | Paid Holidays | Paid sick time | Paid vacationEntry-level Full TimeSan Diego - Mission Valley, United …5d ago
-
Group Leader - Senior Director, Quantitative Pharmacology and Pharmacometrics (Hybrid or Remote) USD 210K-331KADME | Biologics | Biopharmaceutics | Clinical Development | Clinical Pharmacology401k | Annual bonus | Compassionate days | Dental insurance | Hybrid workSenior-level Full TimeUSA - Pennsylvania - West Point, … R6d ago
-
Director, Spend Analytics USD 131K-206KAnalytics | Automation | Contract analytics | Data Governance | Data IntegrityExecutive-level Full TimeOvation Healthcare - Remote CST, United … R6d ago
-
Analytical Control Strategy | CMC documentation | Cell-based potency assays | Cell-line engineering | Clonal Isolation401k match | Company holidays | Dental insurance | Life insurance | Long-term disabilityMid-level Full TimeUSA - MA - Lexington, United …6d ago
-
Director-Advanced Analytics USD 210K-316KAWS | Azure | Causal Inference | Data Lakes | Data Visualization401k plan | Disability benefits | Employee assistance program | Employee wellness programs | Life insuranceExecutive-level Full TimeUSA:TX:Dallas / One AT&T Plaza (208 …6d ago
-
Business Director - Credit Analytics USD 209K-263KCredit Risk | Credit forecasting | Data Analysis | Financial Services | Hypothesis TestingExecutive-level Full TimeMcLean, VA, United States6d ago
-
Director, Data Analytics, Internal Audit USD 170K-190KArtificial Intelligence | Artificial Intelligence Use Cases | Audit Methodology | Automated testing | Azure CloudEntry-level Full TimeNY-300 Madison Ave., 6th Floor, United …6d ago
-
Director of Data Science USD 155K-223KA/B | A/B Testing | Amazon SageMaker | Amazon Web Services | B testing401k | Dental insurance | Medical insurance | Paid time off | Vision insuranceExecutive-level Full TimeDallas, TX, United States6d ago
-
AVP Program Integrity - Ideation and Analytics USD 167K-250KAnalytics | Audit Methodologies | Audit operations | Automation | Claims EditingWork from homeExecutive-level Full TimeWork@Home USA, United States6d ago
-
AGV | AMR | Artificial Intelligence | Automated inspection | CAPA401k | Long-term incentive program | Medical/Dental/Vision insurance | Paid time offMid-level Full TimeChicago, IL, United States R7d ago
-
Director, Technical Program Management (Ranking AI) USD 240K-309KAd-Tech | Agent Orchestration | Artificial Intelligence | Bias Mitigation | Co-designExecutive-level Full TimeSunnyvale, CA | Bellevue, WA | …7d ago
-
Healthcare Technical Consulting Director - Financial Performance, EPM, Data Analytics & Visualization USD 170K-290KAdaptive Planning | Audit Readiness | BI and analytics | Contribution Margin | Cost AllocationTravel opportunitiesExecutive-level Full TimeChicago - 550 Van Buren, United …7d ago