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Director, Analytical Development and Quality Control

Altos Labs
San Francisco Bay Area, CA
Full-time

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.

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.

We are building a company where exceptional scientists and industry leaders from around the world work side by side to advance a shared mission.

Our intentional focus is on Belonging, so that all employees know that they are valued for their unique perspectives.

At Altos, 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 an experienced analytical and QC leader to join the Technical Operations team within the Institute of Medicine.

The candidate will work in a highly dynamic and cross-functional environment and span multiple therapeutic areas. The successful candidate will lead analytical development and quality control for Altos AAV Gene Therapy programs.

Responsibilities

  • Lead analytical development and quality control for AAV gene therapy programs
  • Build a high performing team and establish internal and external analytical and QC capabilities
  • Manage contract manufacturing organizations and contract testing organizations to develop and qualify analytical testing methods, perform release and stability testing, and in-process testing
  • Establish product specifications to ensure product quality. Support technical assessment of Out of Specification and Non-Conforming investigations.
  • Author, review, and / or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents
  • Create and foster strong partnerships with Institutes of Science, development sciences, clinical, regulatory, program management, science integrations, business development, legal and finance
  • Actively contribute to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion

Who You Are

Qualifications

  • Ph.D. or equivalent in analytical sciences or biological sciences. Minimum 10+ years of analytical development and QC experience in biotech / pharmaceutical industry.
  • Highly experienced in developing and implementing assays for AAV gene therapy products in Quality Control testing and characterization of drug substance, drug product and in-process samples.
  • Analytical experience in proteins, oligonucleotides and small molecules a plus
  • Proficient in cGMP’s and pharmaceutical industry procedures and regulations
  • Experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations.
  • Strong communication and collaboration skills. Build effective relationships and partnerships with internal and external stakeholders
  • Proven capability to lead, motivate and inspire in a diverse, global, cross-functional structure and commit to diversity, equity, and belonging.

The salary range for Redwood City, CA :

Director : $229,500 - $310,500

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 diversity, 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.

30+ days ago
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