Associate Director, Pre-Commercial Launch Lead (GOLT Lead)(12 months fixed term

Position Summary

The associate director, Pre-commercial launch lead role (GOLT lead) sits within the Alexion Product Management Team in Global Supply Chain & Strategy and has a critical role in partnering with the Strategic Product Leads (SPLs) to develop and delivery operational launch strategies. The person in this role will align, lead, collaborate and influence across functional barriers to establish supply chains and execute global product launches of new products and new product presentations.

Our New Product portfolio has grown significantly as we grow as a company. We are handling a growing level of complexity with the launches we are leading and this role plays a pivotal part in managing this complexity—including small molecules, biologics, and external partnerships while accelerating launch timelines.

The Pre-commercial launch lead (GOLT Lead) works to ensure that the Global Operations Launch Teams (GOLTs) operate effectively and deliver the operations launch strategy agreed with the Global Program Teams (GPTs) and with the PDCS (Product Development & Clinical Supply) CMC Teams. Additionally, the position will be asked to manage/own one or more key business processes related to launch of new products.

Principal Responsibilities

• Work closely with PDCS CMC Program Management team to ensure the transition from PPQ to launch batches at all manufacturing stages (DS, DP and FP)

• Lead Global Operations Launch Teams (GOLT) to successfully execute global launches. Do this by leading multi-disciplinary teams and working with our markets worldwide ensuring:
  • Our supply chains are launch ready
  • Timely supply of registration samples, packaging and artwork for submission
  • Delivery of launch stock for market launches

• Lead all regional or market specific launch meetings to confirm and align on launch assumptions, including product security features, EAP/ Clinical transition to commercial SKU, and potential risks

• Complete preparation/planning/ risk management for launch supply including securing availability of API/BDS & formulated product in alignment with Reg waves of submission/approval

• Engage actively with partners across the business to understand the global launch expectations, market scope/requirements and potential needs for acceleration,ultimately ensuring the timely delivery of launch stock to markets

• Drive continuous improvement initiatives, focusing on process standardization, automation and digitization related to launch activities

• Act as Project Manager for the onboarding of new manufacturing sites (internal and external) selected for the launch of new molecule entities or for the launches of new product presentations
• Responsible for the transition from GOLT to Brand Expansion team to ensure the continuity of launch activities for tail market launches
• Proactively manage complex risks and challenges using supply chain knowledge and network insights to develop innovative solutions. Ensure these solutions are embedded and shared across the business

• Build strong relationships across the global organization, displaying cultural awareness and adaptability

• Ensure compliance with GMP and regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility

• In addition to the GOLT responsibilities, the GOLT lead will also be asked to manage/own one or more key business processes

• In accordance with our values, you will deliver the solutions needed by being entrepreneurial and patient focused

Qualifications

• 5+ years working experience in a biopharmaceutical or pharmaceutical company having held accountability for the implementation of high-profile projects, ideally in operational launch readiness or Life Cycle Management
• Project management experience in Pharmaceutical or related environment
• Knowledgeable about Smartsheet and other Project Management tools/systems
• Experience of working cross-functionally with R&D and Commercial in a matrixed environment
• Excellent level presentation skills and polished written and oral communication ability
• Ability to engage with senior management in Operations and cross-functionally
• Experience in identifying areas for improvement and driving process changes
• Good understanding of Risk Management
• Strategic thinking, balancing short and long-term priorities

Education

• Science, Engineer or Business Degree required    
• Project Management Qualification desired
• Advanced degree (MS, PhD, MBA) is an advantage

Date Posted

21-Jul-2025

Closing Date

20-Aug-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.