Senior Scientist, Potency Assays - Analytical Development and Quality Control

What You Will Contribute To Altos

The Altos Institute of Medicine will capture knowledge generated about cell health and programming and develop transformative medicines. We are seeking a highly experienced senior scientist in bioassay analytical development and quality control to join the Technical Operations team within the Institute of Medicine. The candidate will work in a highly dynamic and cross-functional environment. The successful candidate will lead analytical development and quality control for potency assays. Modalities include AAV gene therapy, mRNA and protein therapeutics.

Responsibilities

• Lead development of a phase-appropriate potency assay, with an initial focus on AAV gene therapy programs.
• Establish internal capabilities, and design and develop an assay for in vitro assessment of AAV potency, including optimization of multiple steps to build a robust, reproducible and accurate ddPCR-based potency readout for release of DS/DP.
• Lead the timely transfer of the developed assay to external vendor/s for QC testing and manage external assay development/qualification for release and stability testing of potency at the CRO.
• Serve as a technical expert in CMC-appropriate potency assessments, establishment of product specifications to ensure product quality and OOS/OOT investigations.
• Author, review, and/or approve Standard Operating Procedures, development reports, qualification protocols and reports, specifications, regulatory filing and/or other controlled documents. 
• Collaborate cross-functionally with process development, quality control, QA, Institutes of Science, development sciences, clinical, regulatory, program management, legal and finance.
• Recruit and provide direction and training to development associates as the team expands.
• Stay abreast of industry trends, emerging technologies, and regulatory guidelines to contribute to the continuous improvement of analytical methods, quality control and specifications.
• Actively contribute to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion

Who You Are 

Qualifications

• Ph.D. in analytical sciences or biological sciences. Minimum 6+ years of analytical development and QC experience in biotech/pharmaceutical industry.
• Highly experienced in developing and implementing potency assays for AAV gene therapy products including data analysis methods for relative potency, and QC testing for release, in-process and stability.
• Proficient in phase appropriate qualification/validation requirements, cGMP’s and pharmaceutical industry procedures and regulations.
• Strong problem-solving skills with the ability to interpret complex data sets.
• Experienced in achieving CMC deliverables for QC bioassays outsourced to CROs.
• Knowledge of regulatory requirements and quality standards related to release of AAV DS/DP.
• Ability to work in a dynamic environment, with a willingness to learn new skills and adapt to shifting priorities and tasks. 
• Excellent communication skills. Proven capability to collaborate effectively in a diverse, global, cross-functional structure and commit to diversity, equity, and belonging.

The salary range for Redwood City, CA:

• Senior Scientist I: $165,000 - $248,400
• Senior Scientist II: $207,000 - $277,200

Exact compensation may vary based on skills, experience, and location.

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Last updated on Aug 12, 2024