Senior Scientist, Analytical Development

Job Description
The Senior Scientist Analytical Development will play a key role in the analytical development of target and biomarker assays to support the full lifecycle of lentiviral Cell & Gene Therapy programs.

The role is based primarily in the lab, with the opportunity to mentor or manage more junior members of the team.

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Responsibilities:

• Independently lead and perform the design, development, and transfer of biological assays in alignment with phase-appropriate risk-based strategies and project timelines
• Represent the CAD team and serve as technical subject matter expert on cross-functional strategy teams.
• Lead one or more technical-oriented cross-functional teams
• Provide management, mentorship and technical leadership of analytical development processes to train junior scientists and build in-house analytical capability
• Identify new technologies and methodologies to meet program needs
• Oversee the development and qualification of analytical test methods at outsourced Contract Research Organizations (CROs), in accordance with regulatory guidelines and standards, including management of associated deliverables, budget, contracts, and timelines
• Author study plans, procedures, and reports
• Perform statistical data analysis and data QC
• Adhere to ALCOA+ principles for data integrity and documentation

Qualifications:

• Masters' degree and 5+ years of experience in analytical assay development within a biotech/pharmaceutical development context
• Proven track record of high-impact contributions in analytical development and assay development
• Strong knowledge of industry regulatory guidance (FDA/EMA) for the validation of analytical methods
• Proven ability to qualify or validate assays for CMC or clinical purposes is required
• Ability to design and execute a study plan aligned with the activity scope, applicable regulatory guidelines, program timelines and priorities.
• Prior experience with lentiviral therapy programs or lysosomal storage disorders is highly preferred
• Ability to partner across a matrixed environment and work well in a team
• Knowledge of GLP and/or GMP as relevant to laboratory practices in sample handling and analysis
• Flexibility to work on multiple projects as the portfolio evolves over time
• Excellent organizational, documentation, and communication skills; attention to detail, adaptive learning, critical thinking, and multi-tasking
• Experience with regulatory submission preparation is desired