Altos
Senior Director / Executive Director, Analytical Development and Quality Control
Altos, Redwood City, California, United States, 94061
What You Will Contribute To AltosThe 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 AreQualifications
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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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 AreQualifications
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.
#J-18808-Ljbffr