Scientist II, Analytical Development, Bioassays

Role Summary

Scientist II on the Analytical Development team responsible for supporting the development of gene therapy potency bioassays for AAV programs. Reporting to the Senior Scientist, you will contribute to discovery research, process development, and quality control while collaborating with QA, clinical research, regulatory affairs, program management, legal, and finance to advance gene therapy candidates to patients. Location: San Diego, CA (onsite).

Responsibilities

• Design, develop, and execute assay development strategies to produce analytical methods for release and stability testing in a GMP environment
• Serve as a subject-matter-expert for phase-appropriate in vitro potency assays
• Collaborate with research, quality control, and process development teams to develop, transfer, and qualify early phase AAV gene therapy cell-based biological potency assays
• Develop Phase I-appropriate analytical potency bioassays and continue refinement of methods through later phases of method lifecycle
• Monitor analytical method performance
• Actively contribute to the enabling and improvement of analytical development capabilities and processes to support the Quality Team at Insmed Gene Therapy
• Draft and review protocols, SOPs, development reports, and other investigational product documents
• Maintain the Analytical Development laboratory, reagents, and instruments
• Software Use Expectations:
  • JMP or equivalent software for data analysis, assay tracking and trending, and establishment of system and sample acceptance criteria
  • Learn and become proficient in all laboratory instrument software for method development
  • Integration of automation into existing workflows
• Ensure the accurate documentation and record keeping of all lab work, in adherence with current Good Documentation Practices
• Perform data review to ensure accuracy, completeness, and reliability
• Participate in cross-disciplinary mentoring and training of associate scientists
• Assist with coordination and day-to-day management of site operations

Qualifications

• BS or equivalent in biochemistry, cell biology or related field, with a minimum of 5 years of relevant experience; or Master’s degree in relevant discipline with a minimum of 3 years of relevant experience; or PhD with a minimum of 1 year of relevant experience
• Deep technical understanding of, and hands-on experience with, molecular biology, recombinant DNA technology, gene editing techniques, and cell biology
• Cell culture, western blot, electrophoresis, ELISA, flow cytometry, PCR/qPCR/ddPCR, microscopy (bright field, fluorescent, confocal, etc.)
• Experience in optimizing methods with particular emphasis on cell-based potency assays, molecular biology assays, microscopy, and protein chemistry assay
• Proven track record in method development, including experimental design, execution, and evaluation
• Ability to set and meet experimental timelines, ensuring project progression
• Excellent organizational and communication skills (verbal and written), with a strong attention to detail, clarity, accuracy, and conciseness
• Ability to thrive in a dynamic work environment and show commitment to diversity in individuals and ideas, with a strong willingness to take on new challenges required to bring novel medicines to the clinic
• Nice To Have (but Not Required): Significant experience in an FDA-regulated environment is a plus, specifically in the pharmaceutical industry with a GMP testing focus

Skills

• Deep technical understanding of molecular biology, recombinant DNA technology, gene editing techniques, and cell biology
• Cell culture, western blot, electrophoresis, ELISA, flow cytometry, PCR/qPCR/ddPCR, microscopy
• Experience in optimizing methods for cell-based potency assays, molecular biology assays, microscopy, and protein chemistry assays
• Proven track record in method development, including experimental design, execution, and evaluation
• Ability to set and meet experimental timelines and drive project progression
• Strong organizational and communication skills

Additional Requirements

• Travel: 0-15% domestic and/or international travel for method transfer activities and other business-related travel