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 inspectionsLead 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.

Project Management

Organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines and ensuring on-time delivery and right first time by integrating with partner areas.

Strategic Thinking and Working across Boundaries

Thinks and acts beyond one’s silo.Bridges boundaries across teams, functions, divisions, geographies, external stakeholders, and customers.Practices and sponsors Inclusive Behaviours and mindsets in the flow of work.

Productive Communication

Plans and delivers ideas and information to others in a clear and impactful manner.Continuously communicates to align with partners and stakeholders.Communicates effectively with direct reports and employees.

Leadership & Managerial

Sets clear performance standards including stretch goals for self and workgroup.Overcomes obstacles.Holds self and others accountable for achieving results.Works proactively to remove barriers to achieving and exceeding goals.Communicates a sense of urgency, high performance bars and changes to deliverables in a timely manner with workgroup and stakeholders.

Build Talent

Utilizes standard performance management and talent management processes.Build diverse talent within the workgroup with the capabilities necessary for future success.Continuously assess competencies versus future needs and plan to fill gaps.Reward and develop employees to ensure individuals reach their full potential.

People Management

Builds and invests in an Open, Collaborative, and diverse organisation culture.Is an experienced Coach and teacher of people.Demonstrated application of culture and business change methodologies (e.g. Change Execution Methodology, Inclusive behaviours, etc) when realizing site and cross functional process improvement initiatives. Demonstrates Inclusion and Leadership behaviours, including integrity, resilience, and flexibility.Ensures team members have the skills and capabilities to do their jobs.Maintains and develops empowerment.Ensures regular team communications using the Tier Process.Oversees conflict resolution.Oversees and carries out Performance Management, Talent Management activities, including employee development plans.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/7/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R334255