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, supply chain, 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.
• 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 Development, Regulatory, 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.

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 sr 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.
This is a hands on position supported by a strong team of external consultants.