MSAT Site Lead SM Cork

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MSAT Site Lead - SM Cork

Location: Cork Ireland
Company: Janssen Pharmaceutical Sciences Unlimited Company

Why this role matters

At Synthetic Manufacturing site at J&J Cork site MSAT (Manufacturing Science and Technology) keeps manufacturing strong today and makes it better tomorrow. As MSAT Site Lead you will steer the sites MSAT agendanew products lifecycle support validation and process improvementso teams can supply patients with confidence. You will partner daily with Operations and Quality and connect the site to the global J&J network. Youll also represent MSAT during audits and inspections.

If you like solving real plant problems leading technical teams and turning data into better performance youll fit right in!

What you will do

• You will run the MSAT program at site level. You will act as the single point of contact (SPOC) for MSAT and translate global strategy into clear local priorities and plans.

• You will lead and develop a team of engineers. Youll set direction mentor performance assign work based on risk and business need and build flexibility across products and business units.

• You will drive new product introductions and transfers. That includes shaping scope and objectives completing technical assessments and fit-to-plant work building the project plan and coordinating with Technical Launch partners and crossfunctional collaborators.

• You will own MSATs validation accountability for process and cleaning validation working closely with global MSAT subject matter authorities and ensuring MSAT contributions to the Site Validation Master Plan are complete and inspection-ready.

• You will solve and prevent issues by monitoring process and product performance through CPV lead or support complex investigations and implement targeted improvements based on data.

• You will bring in innovative ways of working. Youll evaluate and introduce technologies (including PAT and analytics tools) standardize practices with other MSAT site leads and help deliver CapEx projects with strong technical recommendations.

• You will show up when it counts. Youll provide technical support during regulatory inspections and audits and serve as the MSAT spokesperson for MSAT processes during internal and external audits.

• You serve as API Technical Owner for a synthesis or lead Technical Owners within your team.

• You will connect beyond the site. Youll collaborate across the global MSAT network to share learning and build common approaches and youll engage with external partners such as academia consortia and industry groups when useful.

What you bring

• Bachelors or Masters degree in a relevant scientific or engineering field with 10 years of experience in pharmaceutical manufacturing/technical operations.

• Working knowledge of cGMP expectations process safety and environmental standards.

• Experience leading technical work across technology transfer/NPI lifecycle support investigations and improvement work in a regulated environment.

• 58 years of leadership experience either through direct people management and/or matrix team leadership.

• A leadership style that builds trust develops people and gets multi-functional teams to results.

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