Head of Manufacturing, Science

2 days ago


Kallang, Singapore AstraZeneca Full time

**AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading biopharmaceutical companies. We’re also a Great Place to Work.**:
**This is a collaborative environment where people are empowered to push the boundaries of science and unleash their entrepreneurial spirit. Welcome to an inclusive culture that champions diversity and collaboration. Experience the benefits of lifelong learning, growth and development. There’s no better place to make a difference to medicine, patients and society - and there’s no better time to join our exciting journey to pioneer the future of healthcare.**:
**Position Overview**:
**The person in this role is a key member of the Singapore Operations Leadership Team and is responsible for ensuring that the site delivers on all relevant metrics and KPI’s associated with successful plant start up, new product introduction, regulatory approvals and on-going supply activities.**:
**This role reports into the Client Lead, Singapore Operations. The role will be Singapore based, with some travel to Europe required during facility design.**:
**Scope and Deliverables**:

- ** Site MSAT**includes Process Validation, Process Optimisation along with technical oversight and support for all manufacturing areas (mAb, Drug Linker, DS Conjugation, vial filling & secondary packaging).**:

- ** Process Development and Optimization**:Lead the tech transfer, scale up and optimization of ADC manufacturing processes. Ensure robust, scalable, and efficient processes that meet quality and regulatory requirements.**:

- ** Technical Leadership**: Provide technical expertise and guidance to the MSAT teams and cross-functional partners. Stay abreast of industry trends and advancements to drive innovation within the facility.**:

- ** Cross-Functional Collaboration**: Work closely with Supply Chain, Manufacturing, Quality, and Engineering teams to ensure seamless integration of new products and technologies into manufacturing operations.**:

- ** Troubleshooting and Support**: Oversee the investigation and resolution of process-related issues. Collaborate with manufacturing teams to implement corrective actions and enhance process reliability.**:

- ** Continuous Improvement**: Drive continuous improvement initiatives to enhance process efficiency, yield, and quality. Implement best practices and leverage data analytics to optimize manufacturing operations.**:

- ** Regulatory Compliance**: Ensure all MSAT activities comply with regulatory standards and AstraZeneca’s quality systems. Lead regulatory submissions and support GMP inspections as required.**:

- ** Team Development**: Build and lead a high-performing MSAT team. Foster a culture of collaboration, innovation, and continuous learning. Provide mentoring and development opportunities to team members.**:

- ** Compliance and Quality**: Ensure all technical activities comply with regulatory requirements and quality standards. Collaborate with Quality Assurance and Regulatory Affairs to support audits and inspections.**:

- ** Budget & Resources**: Supporting the development of budget and resource plans to ensure that program objectives are met.**:

- ** Risk Management**: Identifying and mitigating risks that could impact on the successful start up of the facility, and developing contingency plans as needed.**:
**Essential Requirements**:

- ** Extensive experience in a biopharmaceutical or pharmaceutical company in senior MSAT or Process Development roles within the biopharmaceutical or related industry, experience in new facility start up is an advantage.**:

- ** Extensive knowledge of biopharmaceutical manufacturing processes, regulatory requirements, and quality systems.**:

- ** Proven track record of leading successful technical projects and teams.**:

- ** Innovative, with strong focus and proven experience in delivering continuous improvement through the use of the latest process excellence tools.**:

- ** Strong leadership, communication, and interpersonal skills with experience in a matrix environment.**:

- ** Proven ability to analyze complex data and make strategic decisions.**:

- ** Strong problem-solving skills and attention to detail.**:

- ** Demonstrated ability to manage both tactically and strategically, to prepare contingency plans and ensure execution of plans**:

- ** Sound judgment and comfortable operating in a challenging, fast-paced and sometimes ambiguous environment.**:

- ** Knowledge of regulatory requirements for clinical and commercial biopharmaceutical facilities.**:

- ** Demonstrated leadership skills in developing, motivating, and organizing high performing work groups in the biotechnology / pharmaceutical industry.**:

- ** Excellent communication skills—both upwards and downwards and outside the company. Ability t



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