Associate Director, External Manufacturing & Relations Management

Role Summary

Associate Director to drive the advancement and oversight of our Commercial External Manufacturing function. Reports to the Sr. Director External Manufacturing & Relations Management within the Global Supply Chain organization, collaborating with a team committed to innovation, collaboration, and excellence. Manage KalVista's Commercial Contract Manufacturing and relationships for API, drug product, and commercial packaging, fortifying connections with CDMOs and enhancing their performance.

Responsibilities

• Spearhead preparatory activities and mitigating risks for commercial launch(s) with Contract Development and Manufacturing Organizations (CDMOs), while strengthening partnerships and aligning commercial terms with KalVista‚Äôs strategic interests
• Support the formulation and implementation of supplier relationship management strategies to enhance CDMO and key supplier performance
• Analyze production processes to identify areas for improvement and implement changes to drive operational efficiencies and cost effectiveness while maintaining product quality
• Ensure that manufacturing-related activities and projects, such as commercial technical transfers, new raw materials suppliers, and changes in processes or equipment, adhere to established designs, timelines, and budget
• Collaborate with the Supply Planning Director and Finance to ensure accuracy in accruals, invoices, purchase orders, and budget forecasting
• Identify risks associated with CDMO activities and collaborate with CDMOs and cross-functional business partners to develop robust mitigation and contingency plans
• Provide support and drive external quality events, such as deviations and investigations, by offering technical expertise and evaluating process impacts in partnership with CMC and Quality
• Manage end-to-end change control processes from a supply chain standpoint, including change control ownership in coordination with Quality for review, approval, and closure of required actions
• Responsible to administer end-to-end purchase order processes to support supply chain operations and CDMO supply needs
• Maintain risk register for the Supply Chain team. Ensure risks, mitigations and outcomes are escalated/communicated to GSC LT

Qualifications

• Bachelor's degree or higher in science, engineering, or life science field with extensive knowledge and experience in manufacturing, technical transfer and process improvement/optimizations
• Understanding of biotech/pharma manufacturing operations, product and process development, and supply chain operations
• Experience with GMP requirements and interfacing with QA (Quality Assurance), technical teams, and external collaborators required
• Experience in rapid and informed decision making through clear presentation of proposals that balance compliance, customer and cost
• Ability to work in a highly metric-driven environment and deliver against challenging performance targets
• Highly organized and capable of leading/pursuing multiple projects independently
• Independently motivated; excels at driving execution, detail oriented, creative approach to problem solving, and adept at working in a fast-paced environment
• Progressive experience in a leadership role in pharmaceutical development and commercial manufacturing; experience partnering with CDMOs required
• Ability to travel domestically and internationally, as required (approx. 25% travel)