Join Our Crew

Responsibilities Include

• Assist in the design and execution of the external supplier governance structure for the Supply organization
• Manage processes and interactions with key vendors for drug substance and drug product manufacturing (i.e. plasmid, vector, and cell manufacturing)
  • Activities include production management, vendor oversight and relations, issue resolution, communication and collaboration with key stakeholders and partner lines to ensure the required material is released on schedule and meets all necessary requirements
• Lead cross-functional teams internally and with CDMOs to support production across the end-to-end supply chain
• Manage and participate in cross-functional teams of internal and external Subject Matter Experts to conduct thorough investigations related to issues that occur during any operations at external partners.
• Ensure appropriate CAPAs are put in place and enforced to mitigate future risk
• Ensure accurate and timely external supply chain information is available for key stakeholders and management processes
• Design and implement relevant tracking tools to aid management of supply chain activities
• Maintain tracking of applicable Key Performance Indicators (KPIs) to measure and manage the performance of the external supply chain
• Ensure that all contractual obligations with our CDMOs are met to Cabaletta Bio Quality standards, including on-time manufacturing, QC testing, QMS record closure and batch disposition
• Coordinate business review series at CDMOs to review metrics/KPIs/overall health of business and develop strategies to strengthen the partnerships
• Provide front-line support for process- or equipment-related issues at the CDMO and ensure cross-functional engagement internally
• Partner with Process Development, MSAT, and Quality to tech transfer and qualify/ validate manufacturing processes and QC methods
• Assist in contract negotiation and onboarding of new CDMOs
• Travel up to 10% required depending on work location
• Other related duties, as assigned

Required Qualifications

• Bachelors’ Degree in life sciences, engineering, business operations, supply chain or related field with MBA preferred
• 6+ years relevant experience in life sciences manufacturing, supply chain management, or external supplier management
• Experience starting up and/or maintaining an external supply chain organization with appropriate tools, and processes
• Experience in biologics or cell/gene therapy preferred
• In-depth knowledge of GMP regulations and a commitment to operational excellence
• Strong project management and organizational skills and experience.
• Proven strong and visible leadership with the ability and influence other functions within the organization
• Strong relationship-building and collaboration skills; able to work effectively with others, both internally and externally, and resolve conflicts.
• Experience designing and implementing business processes to meet departmental and corporate needs
• Respect and value for diverse thinking with the ability to work multifunctionally across a customer-centric organization
• Comfort with ambiguity
• Experience developing structure and processes to operate efficiently and effectively in a dynamic and evolving environment
• Passion for continuous self-development

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