Sr. Advisor - Analytical Development
USD 141K-228K Senior-level Full Time
Tasks
- Apply statistical design to reduce assay variability
- Author and review analytical and potency sections of regulatory submissions
- Define analytical strategy across product lifecycle
- Drive potency comparability bridging
- Implement novel analytical technologies
- Lead LVV bioassay and potency assay development
- Lead method development optimization troubleshooting and lifecycle planning
- Mentor scientists and build bioassay bench strength
- Optimize qualify validate cell based potency assays
- Oversee external analytical development and technology transfers
- Oversee method transfer to internal and external laboratories
- Provide guidance on product characterization comparability and control strategy
- Provide oversight for specification development
- Support health authority interactions and inspections
Perks/Benefits
- 401k
- Dental insurance
- Employee assistance program
- Fitness benefits
- Flexible spending accounts
- Health insurance
- Life insurance
- Vacation benefits
- Vision insurance
- Wellbeing benefits
Skills/Tech-stack
Analytical Development | Assay Comparability | Assay optimization | Assay qualification | Assay validation | Bioassay | Bridging | CMC | Cell-based assays | DOE | Design of Experiments | EMA | FDA | Functional Reporter Assay | Infectivity Assay | Lentiviral vectors | Matrix Approaches | Method transfer | Multi Attribute Methods | Potency assay | Reference standards | Regulatory Compliance | Regulatory Submissions | Reporter Assay | Statistical design | Statistical design of experiments | Surrogate Potency | Titer assay | Transduction Assay
Education
Regions
Countries
States
Cities
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