Operations Lead

Berkley Group; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

Berkley Group in Ireland is seeking an Operations Lead to act as the primary production process owner overseeing New Product Introduction, Life Cycle Management Projects and CAPEX initiatives. The role requires deep technical and operational knowledge of aseptic Drug Product manufacturing processes and cross-functional collaboration with Facilities, Quality, PD and Supply Chain.

The successful candidate will drive the development and approval of Master Batch Records, training materials, and

Qualifications

• Bachelor's degree in a science discipline.
• 3+ years of bio-pharmaceutical manufacturing experience in fill finish or GMP environments.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Strong problem-solving and data-driven decision making.
• Excellent verbal and written communication, GMP documentation, and presentation skills.
• Ability to train and coach manufacturing staff and SME teams.
• Ability to work cross-functionally and escalate issues as needed.
• Eligible working VISA in Ireland or EU passport.

Responsibilities

• Function as the site interface between Product Delivery Teams and ADL Manufacturing operations.
• Collaborate with Facilities & Engineering, Quality, PD and Supply Chain to understand processes.
• Develop, review and approve Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection.
• Develop, review and update Production, Engineering, Operating Procedures and training materials.
• Provide training on scientific/technical aspects of current processes to Direct Manufacturing.
• Support scheduling and execution of Characterisation, Engineering and PPQ runs and assess performance from data and floor observations.
• Provide troubleshooting support on the floor during activity execution.
• Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects.
• Consult with Quality Assurance to ensure GMP standards are maintained in line with SOPs, batch documentation and licences.

Skills

Bio-pharmaceutical manufacturing

Aseptic processing knowledge

Regulatory compliance (cGMP)

Process troubleshooting

Cross-functional collaboration

Training & coaching

Technical writing

Negotiation & influencing

Education

Bachelor's degree in science

Job description

Global Biotechnology company based in south Dublin, Ireland - looking for Operations Lead.

The successful candidate will serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEX projects and established process improvements projects.

This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes.

The role:

• Function as the site interface between the Product Delivery Teams (PDT's), and ADL Manufacturing operations.
• Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working collaboratively cross functionally with Facilities & Engineering, Quality, PD and Supply Chain.
• Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection.
• Develop, review and update Production, Engineering, Operating Procedures & training materials.
• Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing.
• Support scheduling and execution of Characterisation, Engineering and PPQ runs, ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data.
• Provide troubleshooting support throughout the project and on the floor during execution of activities.
• Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects.
• Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation and licences.

Have You:

• Bachelor's degree in a science discipline.
• 3+ years of bio-pharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Critical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity.
• Negotiation and Influencing skills.
• Take initiative to identify and drive improvements.
• Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills.
• Escalate issues professionally and in a timely manner.
• Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area.
• Teamwork and Coaching others.
• Ensures compliance within regulatory environment.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.