Scientist II, Analytical Development
We're looking for a Scientist II on the Analytical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Scientist, Analytical Development, you'll be part of a multidisciplinary team of scientists focused on the analytical procedure development and characterization of ground-breaking gene therapies. You will author and execute phase appropriate qualification/validation protocols and reports of AD/QC methods to support product release and characterization. What You'll Do: In this role, you'll have the opportunity to develop, improve, implement, transfer and co-validate robust vector genome titer assays with a receiving laboratory (QC internal/external). Your work will also encompass the development of NGS sample preparation methods and the operation of both short read (Element) and long read (PacBio) NGS instruments to characterize AAV drug products, cell lines, and other R&D and CMC samples. You may also be involved in supporting process development activities with potency assay testing and participate in CMC team and governance team activities as needed. You'll also:
- Serve as a subject-matter-expert for vg titer, NGS assays and data interpretation.
- Execute protocols to qualify/validate vg titer assays and characterize AAV drug products and potency assay cell lines.
- Write and review methods, protocols, reports and other product development documents to support filings (INDs/BLAs) and regulatory interactions (briefing books, etc). Will act as a SME during interactions with health authorities as needed.
- Define and implement state-of-the art PCR and NGS sequencing technologies for characterizing all facets of our drug products.
- Design, execute and troubleshoot Next-Generation Sequencing (NGS) assays including nucleic acid (DNA/RNA) purification and library preparation for various sequencing applications including Whole- Genome Sequencing (WGS), Whole-Exome Sequencing (WES), RNA-sequencing, target-enrichment, amplicon sequencing and custom workflows.
- Work with the bioinformatics team to develop and improve tools and pipelines.
- Operate, maintain, and troubleshoot short read (Element) and long read (PacBio) sequencing platforms.
- Maintain accurate, detailed, and timely records of analytical procedure development, experimental data, and data analysis utilizing an electronic lab notebook.
- Perform data review to ensure accuracy, completeness, and validity.
- Participate in cross-disciplinary mentoring and training of associate scientists.
- Present scientific results to the larger Insmed research and technical operations groups, and external scientific community, as needed.
- Strong experience with nucleic acid sample preparation, primer/probe design, qPCR/ddPCR, and NGS
- Experience developing, optimizing, and troubleshooting short- and long-read sequencing methods
- Demonstrated success in method development, including experimental design, execution, and evaluation
- Hands-on experience with routine protein characterization techniques such as spectroscopy, SDS-PAGE, western blot, ELISA, and capillary electrophoresis
- Experience using JMP or equivalent statistical software for data analysis, assay control charts, and assay acceptance criteria
- Excellent written and verbal communication skills
- Highly organized with strong attention to detail, clarity, accuracy, and conciseness
- Strong analytical and problem-solving skills
- Ability to thrive in a dynamic work environment and a demonstrated commitment to diversity of individuals and ideas
- Familiarity with commercial bioinformatics pipeline interfaces (e.g., GeneData)
- Experience in an FDA-regulated, pharmaceutical GMP testing environment
$127,000.00-165,500.00 Annual Life at Insmed At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include:
- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
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