Senior Scientist, Analytical Development
$140,000–$155,000 year
On-siteSouth Boston, Massachusetts, United States
Job Summary
Lead a team responsible for the development, optimization, and technology transfer and qualification of cell-based assays for Drug Products and Drug Substances across the CRISPR portfolio, including potency assays for ex-vivo and in-vivo programs. Qualify and maintain cell lines for various potency assays using flow cytometry-based platforms, while trending potency data to establish specifications for lot release and stability studies. Provide technical and operational oversight to contract labs supporting cell-based potency tests for multiple products and author sections of regulatory briefing packages or submissions. Maintain awareness of applicable regulatory guidelines including ICH, USP, EP, and JP. Fully on-site location in Boston or San Francisco with base pay of $140,000 to $155,000 plus bonus and equity.
Required Qualifications
- Ph.D. in Biology, Chemistry, Chemical Engineering or related discipline
- 4 -8+ years of post-PhD relevant industry experience
- non-PhD with 12-15 years of relevant experience
- Proficient in mammalian cell culture
- Proficient in flow cytometry
- Proficient in droplet digital PCR
- Proficient in sanger sequencing
- Proficient in amplicon next generation sequencing platforms
- Proficient in statistical analyses software, including JMP, GraphPAD, Qubas, Softmax, FlowJo, MACSQuantify
- Proficient in parallel line analysis for interpretation of potency data
- Expertise applied to both ex-vivo and in-vivo cell and gene therapy platforms
- Maintain awareness of applicable regulatory guidelines in area of expertise, including but not limited to guidelines from ICH, USP, EP, and JP
- Ability to mentor a team of scientists into increasing responsibility
- Experience with authoring regulatory submission documents
- Experience with leading analytical method transfer and supporting process technology transfer
- Awareness of regulatory guidelines in FDA and EMA guidance documents, CFR, ICH, USP, and Ph. Eur.
- Proficient in risk assessments to support comparability assessments, process and method changes, and establish drug product critical quality attributes
- Ability to work in cross functional teams supporting product development and tech transfers
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission
- Sense of urgency in solving problems
- Entrepreneurial Spirit – Proactive
- Ownership mindset
- Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site
Desired Qualifications
- Experience in leading assay lifecycle management for Cell and Gene Therapy products
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