Principal Scientist, Engineering

Job Description

A fantastic opportunity has arisen in Dublin (Biotech), for a Principal Scientist, MS&T Engineering. Our state-of-the-art, digitally advanced facility delivers life changing biotech medications to patients all over the world at speed and scale.

The MS&T organization ultimately serves as the product and process subject matter experts for the site and drives the continuous improvement in cost, yield, and compliance outcomes. Reporting to the Site Manufacturing, Science and Technology (MS&T) Lead and based at the Biotech Dublin site, the In-Line Process Support Lead and their Team, provides support to manufacturing operations including direct responsibility for troubleshooting, complex deviation management, change management, process improvement, health authority inspection support, and more. The In-Line Process Support Lead will align with the Dublin site MS&T Lead, and as needed with site and Large Molecule Technical Operations, Operations, Site Quality, Reg CMC, Digital/IT, Engineering and EHS leaders to deliver functional excellence and standard approaches. As part of the MS&T Leadership Team and Site Extended Leadership Team (ELT), The In-Line Process Support Lead and is responsible for ensuring the required competencies, talent management and development of people within their Team, and the wider MS&T Team using the Enterprise Leadership Skills (ELS) as a foundation for this growth.

This leader will create the environment in the group for collaboration across the interconnected, interdependent global network for all the areas of responsibilities within scope, demonstrating a Boundary less Organization mindset (right people, place, time). This includes personal engagement, sponsorship of active participation in management of knowledge, communities of practice, technical networks, product stewardship, technology platforms and best practices sharing in the flow of the core work.

Key responsibilities will include: 

• Lead with Technical Excellence through: Commercial Manufacturing support, introduction of new processes to the site, supporting franchise/network investigations and initiatives, Regulatory strategies for filings and inspections and a relentless focus on problem solving through structured analysis underpinned by the Production System – MPS)
• Problem solving within the site Integrated Production Team (IPT) structures.
• Supporting experimental design, execution, data analysis and interpretation. 
• Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
• Supporting deviation management and timely closure against site metrics.
• Supporting change control prioritization and implementation and compliant closure.
• Authoring and reviewing of batch documentation, technical reports, and global regulatory submissions.
• Supporting multidisciplinary teams (e.g. Manufacturing Science and Technology, Quality, Analytics, Regulatory) for process improvement and troubleshooting with end-to-end product focus.
• Serving as a key site Leader during internal and external inspections
• Lead and support various site and manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
• Top of Form

Your profile:

• This role requires an experienced individual with a minimum of 10 years’ (for PhD), 12 years’ (for MSc) or 14 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.

Business Acumen and Financial Management

• In-depth knowledge of financial systems (budgets, expenses, product standards and variances.)
• Creates awareness of cost levers, driving productivity at all levels.

Problem Solving

• Gathers and analyses data and effectively responds to new, complex, or problematic situations; creates solutions that drive value for the Company and our customers, incorporating innovative approaches.
• Leverages the Production System (MPS) or equivalent tools, e.g. 8 step problem solving.
• Models and teaches scientific problem-solving approaches to group and peers.
• Demonstrates a lean mindset and drives continuous improvement.