Scientist II, Analytical Development

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