Head of Analytical Development and Quality Control

2 days ago


Emeryville, California, United States Tbwa ChiatDay Inc Full time
Job Summary

We are seeking an experienced and visionary leader to head our Analytical Sciences and Quality Control (ASQC) function. As the Head of Analytical Development and Quality Control, you will be responsible for developing and implementing phase-appropriate analytical methods and testing strategies for complex biologicals, including plasmid DNA, mRNA, lipid nanoparticles, proteins, and viral vectors.

Key Responsibilities
  1. Strategic Leadership: Establish and lead the ASQC strategy, including tactics, timelines, budgets, and resource allocation. Build and mentor high-performing teams, proactively identify and resolve critical analytical issues, and support talent development and engagement.
  2. Analytical Development: Develop and qualify phase-appropriate methods for release, characterization, and stability of complex biologicals, utilizing state-of-the-art technologies and approaches. Oversee the qualification, transfer, and execution of analytical and bioanalytical assays, ensuring compliance with cGMP regulations and ICH guidelines.
  3. Lifecycle Management: Provide strategic oversight for the design, establishment, and execution of processes and procedures for the lifecycle management of analytical methods for clinical and commercial product testing. Drive the strategy for product quality assessment, analytical comparability, and characterization.
  4. Regulatory Expertise: Author and review relevant CMC sections of regulatory submissions, serving as an analytical subject matter expert in regulatory interactions. Draft guidelines and set release and stability specifications for clinical-stage and commercial programs.
  5. Cross-functional Collaboration: Partner with internal and external stakeholders to lead Quality Target Product Profile and product characterization strategy, enhancing process-to-product understanding and supporting process development and characterization.
Requirements
  1. Ph.D. in Biochemistry, Analytical Chemistry, Microbiology, Genetics, or a related life sciences discipline.
  2. At least 15 years of experience in analytical development and quality control within the biotech industry.
  3. Industry experience managing scientific teams with a proven ability to lead and grow strong technical teams.
  4. Extensive industry experience with nucleic acids, viral vectors, lipid nanoparticles, and complex biologicals.
  5. Demonstrated expertise in cGMP regulations, ICH guidelines, and USP standards, and their application in clinical development and commercialization.
Preferred Qualifications
  1. Proven ability to build and lead masterful and impactful teams.
  2. Advanced strategic thinking with a focus on product quality assessment, analytical comparability, and characterization.
  3. Proven project management skills, including managing timelines, budgets, and resources.
  4. Excellent communication skills, both written and verbal, with experience in authoring and reviewing regulatory submissions, SOPs, and technical documents.
  5. Strong problem-solving skills, with the ability to resolve complex issues and drive innovative solutions.


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