Senior Pharmaceutical Process Development Leader

MSD; Ireland; On-site; EUR 90,000 - 130,000; Full time

Job summary

MSD in Ireland seeks a Development Engineer to lead the design, scale-up and transfer of solid oral dosage manufacturing processes for commercialisation. You will supervise cross-functional teams, drive quality risk assessments, and ensure robust validation programs align with cGMP and regulatory expectations.

The role involves working with IPTs to transfer new processes to production and optimise manufacturing performance.

Qualifications

• BSc, BEng or higher in Chemical Engineering, Chemistry, Natural Sciences, or related field.
• Minimum 6 years post-graduation in pharma process development, manufacturing, and tech transfer.
• Strong understanding of process chemistry, formulation tech, and engineering for solid oral dosage (OSD).
• Experience with scale-up, technology transfer, and cleaning validation.
• Knowledge of cGMPs, global regulatory expectations, and QRM.
• Experience with deviation management systems and root-cause analysis.
• Excellent written and verbal communication; ability to present data to diverse audiences.

Responsibilities

• Lead design, scale-up, and transfer of OSD manufacturing processes.
• Drive cross-functional teams for QRA, investigations, safety assessments, and process improvement.
• Author and lead process and cleaning validation programs for cGMP compliance.
• Provide high-level technical troubleshooting for multiple manufacturing processes.
• Operate as project leader with robust planning for NPI and tech transfer.
• Identify and implement Lean Six Sigma driven improvements.
• Ensure compliance with quality, environmental, and health & safety standards.

Skills

Process development

Tech transfer

Project leadership

QRM

cGMP knowledge

Root-cause analysis

Lean Six Sigma

Communication

Education

BSc/BEng in Chemical Engineering or related

Job description

MSD in Ireland seeks a Development Engineer to lead the design, scale-up and transfer of solid oral dosage manufacturing processes for commercialisation. You will supervise cross-functional teams, drive quality risk assessments, and ensure robust validation programs align with cGMP and regulatory expectations.

The role involves working with IPTs to transfer new processes to production and optimise manufacturing performance.