Associate Director, External Manufacturing & Relations Management

Role Summary

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

Responsibilities

• Spearhead preparatory activities and mitigate risks for commercial launch(s) with CDMOs, strengthening partnerships and aligning commercial terms with KalVista’s 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 manufacturing-related activities and projects, such as commercial technical transfers, new raw materials suppliers, and changes in processes or equipment, adhere to 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 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 with Quality for review, approval, and closure of actions
• Administer end-to-end purchase order processes to support supply chain operations and CDMO supply needs
• Maintain risk register for the Supply Chain team and escalate/communicate risks, mitigations, and outcomes to GSC LT

Qualifications

• Bachelor's degree or higher in science, engineering, or life sciences with extensive knowledge/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, technical teams, and external collaborators
• Experience in rapid and informed decision making with clear proposals balancing compliance, customer needs, and cost
• Ability to work in a metrics-driven environment and deliver against challenging targets
• Highly organized with the ability to lead/pursue multiple projects independently
• Independently motivated; excels at driving execution, detail-oriented, creative problem solving, and thrives in a fast-paced environment
• Progressive leadership experience in pharmaceutical development and commercial manufacturing; experience partnering with CDMOs
• Ability to travel domestically and internationally as required (approximately 25% travel)

Skills

• Contract Manufacturing Management
• CDMO Relationship Management
• Supply Chain and GMP Compliance
• Technical Transfer and Process Improvement
• Budgeting, Accruals, and Vendor Invoicing
• Risk Management and Contingency Planning
• Cross-functional Collaboration
• Quality Assurance Interface

Education

• Bachelor's degree or higher in science, engineering, or life sciences

Additional Requirements

• Domestic and international travel as needed (approx. 25%)