Role Summary
This Scientist II will independently design, execute, and analyze research studies and will drive one or more analytical development projects for AAV-based gene therapy programs. The role provides technical leadership in the development, optimization, qualification, validation, and transfer of analytical assays, including cell-based potency and molecular methods such as qPCR and ddPCR. The Scientist II will apply broad scientific knowledge and novel approaches to establish AAV mechanisms of action in cellular systems, resolve moderately complex technical issues, and support GMP manufacturing, material release, and regulatory submissions in collaboration with groups across CMC, Quality, QC, and external partners.
The ideal candidate is highly collaborative, detail-oriented, able to manage multiple priorities, and effective in a fast-paced environment. The Scientist II is expected to exercise sound scientific judgment, communicate complex technical issues clearly, build alignment across functions, and serve as a technical resource to colleagues. This is a highly visible and impactful role in our CMC organization.
Primary Responsibilities- Independently design and optimize analytical methods involving in-vitro cell culture and AAV transduction to demonstrate potency of the gene therapy vectors
- Assist in the timely development and internal testing of CQAs, including potency assays, in a target-specific manner
- Generate high-quality, reproducible data to support assay qualification, validation, method transfer, and QC-related activities for GMP material release
- Analyze, interpret, summarize, and communicate findings through technical reports and presentations that clearly describe the scientific problem, relevant literature, experimental procedures, observations, and conclusions
- Assist in driving analytical strategy and support regulatory submissions in collaboration with internal groups across CMC, Quality, and CROs
- Identify technical risks related to assay performance, evaluate relevant factors, and develop mitigation strategies, novel processes, or alternative approaches to solve problems and support continuous improvement
- Collaborate on and review technical documentation and protocols to support late-phase assay validation projects at respective CDMO/CROs
- Maintain accurate laboratory records and ensure compliance with company policies and regulatory standards
- Apply industry best practices, regulatory expectations, and quality standards related to analytical development for gene therapy products, exercising judgment within generally defined practices and policies when selecting methods and techniques
- Apply results and learnings from previous studies, and assimilate knowledge or techniques from adjacent scientific fields, to address new or different problems and achieve project goals
- Collaborate and build constructive relationships across departments; serve as a technical resource and provide scientific coaching and technical guidance within project teams
Required Skills and Qualifications- BS in Biology, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with 6-8 years of relevant experience (MS with 4-6 years or PhD with 1-3 years of relevant industry experience)
- Experience in cell and gene therapy products
- Strong hands-on experience with tissue culture, analytical assay development and execution, data analysis, and troubleshooting
- Experience with pharmaceutical drug-process validation and manufacture a plus
- Knowledge of FDA, cGMP, and ICH guidelines and QBD principles a plus
- Strong organizational skills, attention to detail, and data accuracy
- Excellent communication, collaboration, and problem-solving skills with the ability to work effectively across functional teams
- Cross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity. Results oriented with breadth and depth in pharmaceutical development and commercial products to resolve complex problems
- Results-oriented, with strong initiative, accountability, and willingness to take ownership of projects, deliver milestones, and drive work to completion
- Familiarity with electronic laboratory notebook and inventory systems such as Benchling or Quartzy preferred
$99,680 - $138,500 a year
Compensation is dependent on qualifications and experrience
