VP, Head of CMC

This position has the overall responsibility for the global manufacture of Attovia’s novel biologics platform molecules, from the later stages of discovery trough preclinical and clinical development, up to the commercial and life cycle phase of novel therapeutics.  This individual is accountable for delivering GMP manufacturing of Attovia’s pipeline molecules and to support regulatory filings across all global healthcare regions.  In addition to formulation, process, and analytical development, the position oversees multi-disciplinary international teams supporting Quality oversight, CMO/CRO strategy and execution, and manufacturing technology implementation and transfer.

Key Responsibilities

• Ensure seamless transition of novel biologics from discovery to development, oversee the CDMO selection process. 
• Serve as CMC lead for all of Attovia’s pipeline molecules.
• Lead multidisciplinary cross functional team(s) to develop, manufacture, and supply novel biologics NMEs ensuring adherence to timelines, quality standards, and cost targets. 
• Collaborate with cross-functional team leaders, including development, CMC regulatory, manufacturing, and supply chain teams, to ensure seamless execution of CMC strategies and activities. 
• Ensure compliance with global GMP guidance and regulatory requirements, defined by FDA, EMA, PMDA, and other global health authorities.
• Collaborate with global partners and external vendors to ensure timely delivery of CMC activities and to meet quality standards.
• Drive continuous improvement initiatives to optimize processes, reduce costs, and improve efficiency.
• Partner with key functions (e.g. Clinical Supply, Clinical Development, Clinical Operations, Project Management) in the planning and execution of a manufacturing strategy to meet clinical trial supply requirements.
• Partner with the CTO to evaluate, select, and implement new platform technologies.
• Manage the creation and lifecycle of relevant CMC documentation.
• Stay updated on industry trends, technological advancements, and regulatory changes related to biologics manufacturing and incorporate them into the CMC strategy.
• In partnership with Project and Portfolio Management, continuously monitor and track project progress, budget, and resource allocation, and provide regular updates to senior management.
• Mentor and develop team members, providing coaching and feedback to foster their professional growth and enhance their contribution to the company.

Basic Qualifications

• The successful candidate will have an advanced degree in biology, chemical engineering, or protein chemistry.  
• Must have at least 15 yrs experience in biologics process development and GMP manufacturing from mammalian and/or microbial manufacturing systems. 
• Must have served as senior CMC lead for IND and NDA stage biologics products.  
• Must have experience with CDMO selection and management. 
• Collaborative style and can-do attitude. 
• Comfortable with a fast-paced execution. 

About Attovia 
Attovia is creating a pipeline of biotherapeutics with initial focus immune-mediated disease. The company leverages Attobody™, a novel biologics platform, to generate small format biparatopic binders that expand the addressable target universe across disease areas and can offer stronger efficacy, faster speed to response, and an improved safety profile than traditional approaches. We are currently progressing multiple programs across immune-mediated disease indications. Our culture is centered around five core pillars: • Integrity • Learning & Growth • Drive for Excellence • Innovation • Teamwork & Collaboration 
We take pride in fostering a strong team and dynamic work environment, and we are seeking individuals who align with our values and contribute to a positive and impactful workplace.    Attovia is located in Fremont, CA, with planned future relocation to the mid-Peninsula area in 2025.  Attovia is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  
Learn more about Attovia: www.attovia.com