Senior Associate Manufacturing (Operations Lead)

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Job Description

Senior Associate Manufacturing (Operations Lead)

Job Summary:

The Sr. Associate Manufacturing Strategic Projects role offers the opportunity to collaborate with multiple functions within the Amgen Dun Laoghaire site on a routine basis in a dynamic environment (Quality Assurance Quality Control Engineering Facilities Maintenance Process Development Process Engineering etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility.

The Operations Lead 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; Parts/Components Preparation Formulation Syringe Filling Vial Filling Lyophilisation and Capping.

They will be the operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations.

They will apply process operational scientific expertise basic compliance knowledge and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities.

This role is primarily based on-site at Amgen Dun Laoghaire.

Primary Responsibilities:

Function as the site interface between the Product Delivery Teams (PDTs) 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

Evaluate plan and implement solutions for process improvement opportunities both current and project related.

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

Hold people to account for delivery and behaviours within the Manufacturing Support team and associated with the project(s)

Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing

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 SOPs batch documentation and licences

Develop review and update protocols for manufacturing activities

Documentation and approval of protocol deviations for manufacturing activities

Consult with Process Development Direct manufacturing Equipment and System Owners regarding process changes in an effective and timely manner

Own and lead change controls as required by the Manufacturing Support team

Review Bills of Materials

Develop review and update Product Quality Risk Assessments


Knowledge/Skills:

Strong project management and organisational skills including ability to follow assignments through to completion

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

Demonstrated ability to work independently and deliver right first-time results under minimal direction

Relevant Experience:

Bachelors degree in a science discipline.

5 years of biopharmaceutical 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.