Associate Director, External Manufacturing & Relations Management

About KalVista Pharmaceuticals, Inc. 

KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY®—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world.

For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram.

About EKTERLY® (sebetralstat)

EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom and Switzerland for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide.

For more information visit EKTERLY.com.

 

About the role:

KalVista Pharmaceuticals is in search of an accomplished Associate Director to drive the advancement and oversight of our Commercial External Manufacturing function. Reporting directly to the Sr. Director External Manufacturing & Relations Management within the Global Supply Chain organization, this role entails close collaboration with a team of dedicated professionals committed to innovation, collaboration, and excellence.

The selected candidate will take charge of managing KalVista's Commercial Contract Manufacturing and relationships for API, drug product (DP), and commercial packaging. The primary focus will be to fortify connections with Contract Manufacturing Organizations (CDMOs) and enhance their overall 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’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 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)

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Important Notice to Third-Party Recruiters & Staffing Agencies:

The current job openings advertised on this website are for the sole purpose of candidates to apply directly. Unsolicited and anonymous CVs submitted in any manner to KalVista employees, including to employee personal e-mail accounts, are considered to be the property of KalVista and will not qualify for a fee to be paid. Referral fees will only be payable where KalVista has agreed with an agency to work on a specific appointment, and then only in conjunction with a fully-executed contract for service.

If any Agency representative contacts a KalVista Hiring Manager or company employee, other than a member of the KalVista Talent Acquisition team, to solicit an appointment to engage on a job opening, that Agency will not be considered for that specific job opening or future opportunities with KalVista.

Thank you for your understanding and cooperation.