Advisor, Analytical Development - Gene Therapy
BioSpace · Boston, MA · Yesterday
OTHR$138k–$224k/yrFull-time
Responsibilities
- Lead the design, development, optimization, and qualification of analytical methods for AAV drug substance and drug product, with particular emphasis on cell based potency and activity assays.
- Develop and apply molecular biology based methods (such as qPCR and ddPCR) and separation based methods (such as chromatographic and electrophoretic techniques) for product characterization and release.
- Lead and manage scientists, providing technical direction, development, and oversight within the analytical development team.
- Oversee routine analytical testing in a development environment, ensuring data quality, throughput, and adherence to procedures.
- Independently drive complex method development and troubleshooting, making sound technical decisions with limited oversight.
- Author and review CMC regulatory content for Module 3 submissions, including analytical procedure, validation, specification, and stability sections.
- Coordinate method execution and GMP testing with external CROs, ensuring data quality, protocol adherence, and timely delivery.
- Partner cross functionally with toxicology, quality, formulations, and manufacturing to align analytical strategy with program needs.
- Serve as a subject matter expert in analytical reviews, investigations, and qualification report assessments.
Qualifications
- PhD in analytical chemistry, biochemistry, molecular biology, or a related field with 2+ years industry experience; or a Master's degree in analytical chemistry, biochemistry, molecular biology, or a related field with 8+ years industry experience.
- Demonstrated, hands on experience developing cell based assays from scratch, including assay design, optimization, and qualification.
- Demonstrated experience leading and managing scientists, and overseeing routine testing in a development environment.
- Good foundation in GMP analytical method development and qualification for biologics or advanced therapies.
- Demonstrated experience authoring CMC regulatory documentation.