Director of Large Scale Manufacturing

Introduction to role

As the Director of Large-Scale Manufacturing, you will lead multiple layers and spans within the drug substance manufacturing teams, developing and implementing strategies that align with AstraZeneca’s goals. You will play a critical role in ensuring operational effectiveness within a manufacturing environment while cultivating a culture of innovation and continuous improvement. You will be accountable for daily manufacturing operations, excelling in both strategic vision and operational execution, ensuring compliance, quality, and efficiency across all manufacturing functions under your management.

Accountabilities

• Develop and implement manufacturing strategic plans to improve production efficiency and effectiveness that support company goals and objectives.

• Have direct oversight and accountability for all large-scale manufacturing and production processes.

• Plan and direct manufacturing operations, focusing on drug substance manufacturing.

• Lead all aspects of day-to-day manufacturing operations with a focus on meeting production schedules, run rates, and quality standards.

• Direct end-to-end Manufacturing Department activities including material preparation & cell culture, through bulking of drug substance.

• Lead and mentor a multidisciplinary team, encouraging a culture of innovation, excellence and accountability

• Establish key performance indicators (KPIs) to track operational performance and implementing corrective actions when necessary.

• Analyze production processes to identify areas for improvement and implementing changes to drive operational efficiency and cost-effectiveness while maintaining product quality.

• Provide guidance for establishing the site production plan to support commercial and clinical manufacturing commitments.

• Accountable for projects assigned to Manufacturing.

• Build and sustain a culture that embraces safety—ensuring that all manufacturing operations adhere to safety regulations and company policies.

• Ensure full compliance with all relevant Regulatory guidelines, including cGMP and FDA requirements.

• Participate as a Manufacturing Department Lead in regulatory inspections and other audit types.

• Collaborate with the quality assurance team to influence robust quality systems and address quality issues promptly.

• Develop and manage budgets for manufacturing operations, ensuring financial objectives are met.

• Overseeing the allocation of resources, including personnel, equipment, and materials, to maximize productivity and efficiency.

• Serve as the primary liaison for internal and external partners regarding manufacturing processes.

• Foster interdepartmental collaboration and effective communication.

• Promote a culture of continuous improvement by implementing best practices and process innovations.

• Stay up to date with industry trends and technological advancements to guide strategic decisions.

Essential Skills/Experience

• Bachelor's degree or equivalent experience

• Minimum of 10+ years of proven experience in leadership roles, preferably in the biopharmaceutical industry.

• Broad knowledge and perspective of upstream/downstream/central services operations

• Solid understanding of cGMP, FDA regulations, and quality management systems.

• Excellent leadership, communication, problem-solving, and decision-making skills.

• Excellent influencing skills with demonstrated experience in change management.

• Experience with budgeting and resource management.

• Ability to interpret sophisticated technical instructions and lead multiple projects effectively.

• Ability to define problems, evaluate data, establish facts, and draw valid conclusions.

Desirable Skills/Experience

• Minimum BS/BA degree required in chemical/biochemical engineering or biological sciences/life sciences in pilot or commercial biologics manufacturing

• 15+ years of proven experience in leadership roles in the biopharmaceutical industry.

• Understanding of Lean Six Sigma or Lean Manufacturing is an asset.

• Experience impleme