Senior Scientist, Analytical Development and Quality Control

Our Mission

Our mission is to restore cell health and resilience through cell rejuvenation to reverse disease, injury, and the disabilities that can occur throughout life.

For more information, see our website at altoslabs.com.

Our Value

Our Single Altos Value: Everyone Owns Achieving Our Inspiring Mission.

Diversity at Altos

We believe that diverse perspectives are foundational to scientific innovation and inquiry. At Altos, exceptional scientists and industry leaders from around the world work together to advance a shared mission. Our intentional focus is on Belonging, so that all employees know that they are valued for their unique perspectives. We are all accountable for sustaining a diverse and inclusive environment.

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 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

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 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.

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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What We Want You To Know

We are a culture of collaboration and scientific excellence, and we believe in the values of inclusion and belonging to inspire innovation.

Altos Labs provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. 

Altos currently requires all employees to be fully vaccinated against COVID-19, subject to legally required exemptions (e.g., due to a medical condition or sincerely-held religious belief).

Thank you for your interest in Altos Labs where we strive for a culture of scientific excellence, learning, and belonging.

Note: Altos Labs will not ask you to download a messaging app for an interview or outlay your own money to get started as an employee. If this sounds like your interaction with people claiming to be with Altos, it is not legitimate and has nothing to do with Altos. Learn more about a common job scam at https://www.linkedin.com/pulse/how-spot-avoid-online-job-scams-biron-clark/