Analytical Development Research Scientist

Job Description

General Summary:

The Analytical Development Research Scientist works with a high degree of independence and is adept at designing and executing complex experimental procedures within required timelines. Completes work in a resourceful, self-sufficient manner and is able to troubleshoot and design alternative approaches to achieve desired outcomes. Performs strategic planning consistent with regulatory guidance, implements innovative approaches and maintains a high level of technical knowledge. Authors and reviews method documents, analytical study protocols and reports. Works collaboratively within the analytical development team and cross-functionally with other groups to meet CMC organizational goals. This is a hands-on role combining advanced data analytics with laboratory-based assay development in a cross-functional setting.

Key Duties and Responsibilities:

• Independently conceptualize, develop, and deploy analytical solutions that support characterization of cell-based products
• Perform laboratory experiments supporting analytical method development for gene and cell therapy products, and apply statistical analyses to assess specificity, sensitivity, linear range, precision, and accuracy
• Analyze complex experimental and process data, and create clear visualizations and present findings and recommendations to technical teams and management
• Execute test methods supporting Process Development activities to support process improvements
• Author and review SOPs, protocols, technical reports, and transfer and qualification documentation, and contribute analytical content to regulatory filings
• Maintain clear, accurate, and compliant records, including electronic lab notebooks and test forms
• Stay current with developments in the broader data science community and apply relevant approaches to analytical challenges

Knowledge and Skills:

• Demonstrated experience applying data science and statistical analysis to complex scientific questions
• Ability to independently plan and execute technical work, interpret results, and communicate conclusions to cross-functional audiences
• Advanced data analysis, statistical analysis (e.g. JMP, GraphPad Prism, PLA analysis), data visualization, machine learning, and modeling proficiency
• Strong skills in analytical programming (Python, R, SQL, cloud platforms)
• Hands-on experience with at least one of the following: cell count & viability, cell cluster characterization, flow cytometry, mammalian cell culture
• Assay development, qualification, troubleshooting, optimization, and performance trending

• Characterization and release testing for identity, purity, strength, and potency
• Clear and effective communication abilities
• Independent project leadership
• Ethical data practice adherence
• Experience with ELN/LIMS systems
• SOP, protocol, and technical report authoring
• Knowledge around regulatory guidance for cell therapy and cell-based assay development from FDA, ICH, and USP

Education and Experience:

• Ph.D. (or equivalent degree) and 0-3 years of relevant post-doctoral employment experience, or
• Masters Degree (or equivalent degree) and 3+ years of relevant employment experience, or
• Bachelors Degree (or equivalent degree) and 6+ years of relevant employment experience
• Experience in an analytical development program, providing technical support in a manufacturing setting or technical role in a QC environment
• Experience designing and/or performing assay qualification, including authoring and/or reviewing relevant documentation

Pay Range:
$102,800 - $154,200

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 for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:
On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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