Senior Scientist, 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 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. Modalities include AAV gene therapy, mRNA and protein therapeutics.

Responsibilities

• Lead internal and/or external development of phase-appropriate vector genome (Vg), capsid (Cp) titer, residuals as well as purity and impurity assays, with an initial focus on AAV gene therapy programs.
• Design and develop ddPCR-based assays for Vg titer, host cell DNA and plasmid DNA.
• Design and develop assays for Cp titer by ELISA, Surface Plasma Resonance and/or SEC-HPLC, Purity assay by CE, Full/Empty capsid ratio by AEX and/or SEC-HPLC and/or charge detection mass spectrometry (CDMS). 
• Lead the timely transfer of the developed assay to external vendor/s as needed, and manage external assay development/qualification for release and stability testing at the CRO.
• Serve as a technical expert in CMC-appropriate analytical assays for Vg and Cp titer, Full/Empty ratio and residuals, establishment of product specifications 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 titer assays for AAV gene therapy products including DS/DP and residuals, 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 assays 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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