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 purification process development and manufacturing 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 downstream process development and support outsourced GMP manufacturing for Altos programs. Modalities include AAV gene therapy, mRNA and protein therapeutics.

Responsibilities

• Lead purification process development for AAV gene therapy, mRNA and protein therapeutics.
• Establish internal downstream capabilities, design and execute on studies for purification process improvement and troubleshooting, and produce materials to supply non-clinical studies.
• Manage and collaborate with manufacturing organizations to optimize/ improve downstream purification processes, scale up, and establish in-process control strategies.
• Support GMP manufacturing at CDMOs, review GMP documents, troubleshoot technical issues, support deviation investigation, and lead risk assessment.
• Author, review, and/or approve development reports, regulatory filing, or other controlled documents.
• Collaborate cross-functionally with upstream, analytical development, quality control, QA, Institutes of Science, development sciences, clinical, regulatory, program management, legal and finance.
• Recruit and provide direction and leadership to development associates as the team expands.
• Stay abreast of industry trends, emerging technologies, and regulatory guidelines to contribute to the continuous improvement of processes and compliances.
• Actively contribute to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.

Qualifications

• Ph.D. in chemical engineering, biochemical engineering, biotechnology, or related field of biological sciences. Minimum 8 years of purification process development experience in biotech/pharmaceutical industry.
• Proven expertise in downstream process development for AAV vectors. Experiences in multiple modalities--AAV gene therapy, protein, and mRNA therapeutics, is a plus.
• Hands-on experiences with chromatography, filtration, TFF, and other downstream processing techniques.
• Strong problem-solving skills with ability to interpret complex data sets.
• Knowledge of regulatory requirements and quality standards related to biopharmaceutical manufacturing.
• Experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations.
• 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: $169,000 - $234,000
• Senior Scientist II: $195,000 - $261,600

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

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