Senior Scientist, Analytical Development and Quality Control

Altos Labs • San Francisco, CA

370d • $165,000 - $248,400

About The Position

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.

Requirements

• 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 biologics and/or 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.

Responsibilities

• Lead internal and/or external development of phase-appropriate capsid (Cp) titer, residuals as well as purity and impurity assays, with an initial focus on AAV gene therapy programs.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree
• Number of Employees: 251-500 employees