Director, Analytical Development
MTC North - Norwood - USA - MA, United States
USD 167K-300K Executive-level Full Time
Tasks
- Apply ICH FDA EMA guidelines to assay development and lifecycle
- Develop qualify validate and manage lifecycle of cell based bioassays
- Influence cross functional teams and set assay development priorities
- Lead potency assay strategy for late stage programs
- Oversee potency deliverables and manage assay risks
- Partner with Quality QC and Analytical Sciences to enable method transfer and validation
- Resolve bioassay investigations deviations and comparability assessments
- Support CMC bioassay development for IND BLA submissions
- Support regulatory filings and health authority questions
- Translate product biology into mechanistically relevant assay design
Perks/Benefits
- Family planning benefits
- Fitness programs
- Healthcare coverage
- Mental health support
- Paid time off
- Savings and investment opportunities
- Wellness support
Skills/Tech-stack
Analytical Control Strategy | Assay Lifecycle Management | Assay lifecycle | Assay qualification | Assay validation | BLA Preparation | Bioassay development | CMC | Cell-based assays | Comparability studies | Control strategy | Data Interpretation | EMA regulations | FDA Regulations | ICH Guidelines | IND Preparation | Lifecycle Management | Method transfer | Potency assays | Regulatory Affairs
Education
Regions
Countries
States
Cities
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