Senior Director Process Engineering & Packaging

Job Title: Director Process Engineering & Packaging

Location: Cambridge Biomedical Campus UK

Hybrid Working model - 3 days per week

Introduction

Join AstraZeneca Biologics as a Process Engineering & Packaging Leader and drive innovation in biopharmaceutical process development and technology transfer across our UK and EU operations. This function develops early and late-stage clinical fill/finish processes combination product assembly processes and packaging for biopharmaceutical products in the AstraZeneca Biologics portfolio. This pivotal role offers the opportunity to lead groundbreaking process development for our diverse biologics portfolio whilst building and maintaining world-class technical capabilities!

You will lead a high-impact team of scientists and engineers bringing scientific rigour practical innovation and deep collaboration to sophisticated challenges. How will you elevate design for manufacturability technology transfer and packaging readiness to enable seamless scale-up across a global network Join a supportive community that values kindness alongside ambition where taking ownership and driving outcomes are part of daily practice.

Accountabilities:

Accountabilities include leadership of the UK/EU based team responsible for process development and packaging for clinical products development of robust drug product and device assembly processes for commercial production (in collaboration with Operations) technology transfer to both internal and outsourced commercial manufacturing leading a sophisticated scale-down fill/finish development lab and technical support of clinical and commercial production. You incumbent oversee the process development of diverse group biopharmaceutical dosage forms including liquid and lyophilized formulations various primary container formats novel drug delivery formulations (e.g. nanoparticles high concentration formulations etc.) drug delivery devices and packaging.

The leader must maintain a strong technical culture and be able to establish strong working relationships at internal and external interfaces. This position requires effective collaborative interactions with AstraZeneca Biologics / AstraZeneca leaders particularly with the Global Biological Operations (Commercial Operations) organization and internal/external manufacturing sites within the manufacturing network.

Experience working with functions such as late-stage formulation development device development clinical operations supply chain quality and regulatory are also essential. You will be able to effectively lead in a matrix environment and influence broadly internally and externally.

Major duties and Responsibilities

• Provide technical and strategic leadership and management for the development of drug product and device assembly processes. Scope includes accountability for design for manufacturability development and technical support of clinical and commercial fill-finish processes clinical packaging development and support of commercial packaging technology transfer to internal and external manufacturing sites and ad-hoc technical support for commercial products as needed.
• Apply scientific and engineering knowledge and tools to issues and problems arising during development and execution of manufacturing processes
• Lead and manage a technical team of 8-10 scientists and engineers including resource management prioritisation critical assessment of technical work support of project teams and developing relationships with functional partners
• Lead mentor and develop high-performing teams whilst building the next generation of technical leaders
• Provide leadership and create strategies to evolve the capabilities of the organization in alignment with AstraZeneca Biologics strategies growing health authority expectations and changing external drug product competitive landscape
• Drive a culture of innovation and high-quality science and engineering
• Influence regulatory strategies and provide guidance and reviews of regulatory information packages and filings/submissions
• Challenge the status quo yet build strong relationships with other leaders and functional partners
• Broadly influence and educate senior leaders and the larger AstraZeneca Biologics functional areas and product teams on drug product development
• Create solid partnerships with key interfaces and represent BPD on senior leadership teams committees and councils
• Elevate AstraZeneca Biologics position as the definitive industry leader through dynamic external engagement including presenting breakthrough innovations at premier conferences and spearheading pivotal initiatives within influential manufacturing and device development communities

Essential Skills/Experience:

B.S. M.S. or Ph.D. in Chemical Engineering or other relevant Engineering field Pharmaceutics or related field with 13 years of related experience in the biopharmaceutical industry. Strong technical and scientific skills with proven experience in development of drug product manufacturing processes for biologics in primary containers and devices.

Leadership & Experience

• Recognised industry leader in drug product manufacturing process development with 8 years of progressive managerial experience leading high-performing technical teams

• Comprehensive expertise in developing and delivering pivotal initiatives for drug product manufacturing process development across diverse biopharmaceutical portfolios

• Proven track record of leading enterprise-level committees critical initiatives and multi-functional task forces that drive organisational excellence

Technical Expertise

• Deep technical knowledge of design for manufacturability principles with demonstrated application in biopharmaceutical production environments

• Strong proficiency in Six Sigma methodologies and continuous improvement tools with evidence of successful implementation in manufacturing settings

• Extensive experience in Chemistry Manufacturing and Controls (CMC) aspects of biopharmaceutical development from early-stage through commercial production

• Comprehensive understanding of current industry scientific and technical advancements in drug product manufacturing process development with ability to translate innovations into practical applications

Regulatory & Stakeholder Management

• Substantial experience managing regulatory agency interactions including preparation and presentation of technical submissions and responses to regulatory enquiries

• Exceptional ability to lead and influence cross-functionally at senior organisational levels with demonstrated success engaging and collaborating with executive leadership teams

People Leadership & Development

• Outstanding leadership capabilities in developing and inspiring professional staff across multiple technical subject areas within collaborative matrix environments

• Proven expertise in building high-performing diverse teams whilst fostering a culture of innovation continuous learning and technical excellence

• Strong collaborative approach with demonstrated success working effectively across multiple technical functions and geographical locations

Call to Action:

Bring your expertise to lead the next chapter of process engineering and packagingapply today to shape how life-changing biologics reach patients at scale!

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here mission and momentum meet. You will work at the intersection of pioneering science digital technologies and disciplined execution shaping how molecules become medicines at scale. We bring unexpected teams together to fuel ambitious thinking and we value kindness alongside ambition so you can lead with confidence and be supported to grow. With strong investment a global network and a clear drive to deliver more medicines to patients faster and more sustainably your contributions will have visible impact on patients colleagues and the future of manufacturing.

Date Posted

Closing Date