Senior Scientist Analytical Development – Molecular-based assays - Automation & Testing

Job Description

General Summary:

The Analytical Development Senior Research Scientist consistently demonstrates a high level of strategic planning and experimental execution, working within established timelines. Works with a high degree of independence and demonstrates the ability to lead a team, either formally or informally, to achieve experimental and organizational goals. Takes a leading role in writing documents (method documents, protocols, reports) and demonstrates high-level analytical skills and understanding of data interpretation. Actively seeks cross-functional roles to improve communication between groups and achieve efficiency in achieving organizational deliverables.

Key Duties and Responsibilities:

• Evaluate and develop molecular-based assays to evaluate DNA, genome integrity, and RNA characteristics to support characterization and release assays for identity, purity, strength, and potency for Vertex cell and gene therapy programs.
• Develop, qualify, and implement novel high-throughput (HTP) and/or automated assays for various molecular-based assays, such as ddPCR, qPCR, Nanostring, microarray, and NGS, for biologics or cell and gene therapy.
• Provide manual and automated routine analytical testing for various assays related to cell and gene therapy to support process development, process characterization, and others
• Work closely with Analytical Development and Research teams to translate the manual or LTP based into HTP and an automated method.
• Perform HTP and automated assay qualification to establish specificity, sensitivity, linear range, precision, and accuracy of test methods.
• Develop assay design criteria using Design of Experiments (DOE) and other contemporary development tools.
• Transfer assays to QC or external partners as needed.
• Serve as SME for molecular-based assays across cell and gene therapy programs.
• Enhance data visualization, reporting, and decision making by incorporating novel data automation techniques with python, R, JMP and other software.
• Troubleshoot, optimize, and trend assay performance. Manage analytical reagents inventory, including reference standard materials as per regulatory standards.
• Maintain excellent written documentation of completed experiments (ELN, LIMS) and maintain knowledge share systems (MS-Teams and SharePoint).
• Generate all training procedures for users to ensure the smooth operation of the test method.
• Be a strong team player, contributing to group priorities and deliverables. Training and mentoring junior team members.
• Involved in IND and BLA filings as needed
• Manage and supervise 2-3 contractors

Required Knowledge and Skills:

• Expertise in nucleic acid-based assays development, such as ddPCR, qPCR, Nanostring, FISH, scRNA sequencing, and other NGS methods for cell and gene therapy.
• Expertise in robotic liquid handlers (Hamilton, TECAN, or other) and their operating software (VENUS, Fluent Gx, or other) for automated sample preparation.
• Experience with multiplexing molecular assays.
• Experience with various data analysis and visualization software such as Python, R, PowerBI, JMP
• Proven understanding of cell culture techniques, especially for embryonic stem cells (ESC) and induced pluripotent stem cells (iPSC).
• Experience with other cell and gene therapy assays, such as flow cytometry, immune-based, and cellular-based assays, is a plus.
• Understanding of bioprocessing, cell and gene therapy process development, characterization, and manufacturing.
• Ability to use literature to design proof-of-concept studies.
• Experienced in writing technical documents, including development reports, qualification protocols, and qualification reports.
• Excellent communication and presentation skills with the proven ability to solve complex problems and to work effectively as a member of a multidisciplinary team, detail-oriented, multitasking, goal-oriented, timeline-oriented, and a critical thinker.
• Team player, innovative, collaborative, and an initiator.
• Ability to work and collaborate in a fast-paced environment with a high level of independence to manage projects

Education and Experience:

• PhD in Biochemistry, Chemical Engineering, Cell & Molecular Biology, or related discipline with 3+ years of industry or academic experience

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Pay Range:

$124,400 - $186,500

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible