Senior Scientist – Process Analytical Technology – APICOM Full-time

Senior Scientist – Process Analytical Technology – APICOM (Active Pharmaceutical Ingredient Commercialisation)

Location Dublin

Competitive salary and benefits

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It's inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people's lives better – from patients and their families to all of us in society!

AstraZeneca is a global, innovation-driven biopharmaceutical company where we focus on the discovery, development, and delivery of life-saving medicines to our patients in addition to our belief in sustainability and determination to minimize the impact of our work on the environment. We are proud to be a great place to work and have a culture that inspires innovation and collaboration. We empower our colleagues to express diverse perspectives and at the same time feel valued, respected, and rewarded for their ideas and creativity.

We have an exciting opportunity for an experienced, highly motivated Process Analytical Technology (PAT) Scientist to join the Process Technology Group based at an API Commercialisation Facility (APICOM) being constructed in Dublin. This group will ensure the safe and timely introduction and manufacture of late-stage clinical and commercial API (Active Pharmaceutical Ingredients). This state-of-the-art facility includes the latest manufacturing and digital technologies to support autonomous batch and continuous manufacturing.

As an experienced Process Analytical Technology scientist with a proven record of developing, transferring, and implementing PAT solutions for pharmaceutical drug substance manufacturing, you will be responsible for leading the use of PAT as an enhanced control strategy solution in a modern, state-of-the-art manufacturing facility.

In this role, the successful applicant will provide PAT leadership and expertise whilst collaborating with colleagues from Chemical Development (Macclesfield, UK) to transfer PAT methods from the lab to the APICOM Facility in Dublin. They will also work collaboratively within multiskilled groups within APICOM, including analytical, chemistry, chemical engineering, plant engineers, and plant operators. The role will require proactive planning and coordination with multiple customers to ensure successful and timely implementation of PAT in preparation for a manufacturing campaign.

Key Responsibilities:

• Lead the introduction of several PAT instruments, ensuring that they are maintained and operated in accordance with cGMP.
• Implement Standard Operating Procedures or other guidance documents for the safe and effective use of PAT within APICOM.
• Take ownership of critical business processes related to the transfer and utilization of PAT methods and associated chemometric models, ensuring alignment with industry standards and regulatory requirements. Represent the department as a Subject Matter Expert (SME) during internal and external audits, providing insights and guidance on Process Analytical Technology.
• Coordinate with Chemical Development project teams and local accommodation teams to review manufacturing schedules and ensure availability and readiness of key equipment.
• Receive training and develop experience as a Siemens SIPAT superuser, providing local expert support for the configuration and deployment of SIPAT methods for manufacturing campaigns.
• Represent APICOM on the AstraZeneca global Siemens SIPAT user groups.
• Demonstrate scientific leadership and strategic development of PAT capability within APICOM by driving continual improvements and sharing learning within APICOM/Chemical Development and wider PAT networks within AZ.
• Build PAT capability and experience within APICOM through the training and coaching of colleagues.

Essential requirements:

• Bachelors degree or PhD level education in chemistry, analytical chemistry or chemical engineering with experience of working within a Research & Development and/or Manufacturing environment.
• A strong understanding and proven record for the development and delivery of drug substance control strategies using PAT.
• Significant practical experience using several of the major PAT spectroscopic techniques including near-IR, mid-IR, Raman, UV/Vis and FBRM in either a laboratory or GMP manufacturing environment.
• A strong data-centric mindset with proven ability in the area of chemometrics.
• A thorough understanding of the principles and management of SHE and cGMP for drug substance manufacturing.

Preferred Requirements:

• Experience of managing change within a regulated manufacturing environment.
• Experience in developing, validating, and transferring quantitative multivariate models for real-time PAT monitoring of drug substance unit operations.
• Strong coding skills, preferably in MATLAB or Python.
• Practical experience of using a PAT data management system, such as Siemens SIPAT in a development or manufacturing environment.
• Experience of technical supervision, coaching, and mentoring.
• Experience of introducing new analytical technologies, including defining user requirements, providing training, and establishing standard operating procedures.

Why AstraZeneca:

At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development!

So What's Next:

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.

Find out more on Social Media:

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• About Operations: https://www.youtube.com/watch?v=gak5Ham8oUw

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.