Senior Director, Analytical Development and Quality Control

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 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.

Responsibilities

• 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

Who You Are 

Qualifications

• 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, as well as 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 sta