Senior Director, Analytical Development and Quality Control Jobs

Altos Labs

Location:
United States, Redwood City

Category:
Research and Development

Contract Type:
Not provided

Salary:

283900.00 - 384100.00 USD / Year

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Job Description:

The Altos Institute of Medicine will capture knowledge generated about cell health and programming and develop transformative medicines. We are seeking a highly experienced analytical and QC leader to join the Technical Operations team as the Head of Analytical Development and Quality Control. The candidate will work in a highly dynamic and cross-functional environment that will have close collaboration with the Institutes of Science and span multiple therapeutic areas. The successful candidate will lead analytical development and quality control for Altos programs. Modalities include protein and antibody therapeutics, small molecules, antisense oligonucleotides, mRNA and AAV gene therapy.

Job Responsibility:

Lead analytical development and quality control across multiple modalities
Build a high performing team and establish internal and external analytical and QC capabilities
Serve as CMC lead and analytical lead for Altos therapeutic programs
Manage contract manufacturing organizations and CROs to develop and qualify analytical testing methods, perform product characterization, 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
As a member of the Tech Ops leadership team, build the Tech Ops organization, processes, systems and infrastructure
Create and foster strong partnerships with Institutes of Science, Institutes of Technology, Institute of Computation, drug discovery and development sciences, clinical, regulatory, program management, business development, legal and finance
Actively contribute to a team culture that promotes continuous improvement, accountability, professional growth, and inclusion

Requirements:

Ph.D. in analytical sciences or biological sciences
Minimum 15+ years of analytical development and QC experience in biotech/pharmaceutical industry
10+ years of Management experience
Highly experienced in developing and implementing assays for Quality Control testing and characterization of drug substance, drug product and manufacturing in-process samples
Experienced in multiple modalities including biologics, oligonucleotides, small molecules, mRNA/LNP and AAV gene therapy
Experienced in leading CMC team and analytical subteam
Proficient in cGMP’s and pharmaceutical industry procedures and regulations
Highly experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations
Leadership experience in managing diverse project activities with contract CDMO facilities at global locations
A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs
A big-picture innovator who can identify opportunities and is comfortable with ambiguity
Strong communication and collaboration skills
Clear and influential communicator
Build effective relationships and partnerships with internal and external stakeholders
Proven capability to lead, motivate and inspire in a diverse, global, cross-functional structure
Commit to diversity, equity, and belonging

Additional Information:

Job Posted:
December 05, 2025

Employment Type:

Fulltime

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Senior Director, Analytical Development and Quality Control