Amgen Jobs

Overview:

The Manufacturing Manager - MES at Amgen Dun Laoghaire will report to the Senior Manager Manufacturing and will be responsible for leading a team of MES designers for the generation of Master Batch Records while ensuring they are delivered in compliance with Good Manufacturing Practices and in adherence to the Manufacturing Schedule. They will be responsible for ensuring Master Batch Record delivery for NPI’s/LCM’s, revision of Commercial records from run the business and/or Capital Project updates.

The ideal candidate will have:

• Experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading teams to deliver complex MBR designs in time with project timelines.

• Broad technical experience in MES systems and Master Batch Record delivery.

• Have commitment to continuous improvement to improve efficiency at how team operates.

• Demonstrated experience working in cross functional work center teams with the ability to handle multiple projects simultaneously.

Job Scope:

MES Manager Responsibilities

• Recruitment and on-boarding personnel to ensure MES team can meet project targets and manufacturing schedule adherence in accordance with resource models.

• Monitoring resources and training models to ensure that appropriate resource/staff management to meet project targets

• Assist in the assessment and development of impact and /or resource models for New Product and Project siting assessments

• Develop MES team through training and coaching.

• Manage direct reports ensuring required performance standards are met to create a high performing team

• Particate in the goal setting process for the team and manage complex goals aimed at creating competitive advantage.

• Builds and fosters collaborative relationships within own team and other cross functional teams

• Promote culture of safety ensuring team is engaged and aligned with site safety initiatives

• Support ongoing development and improvement of the Amgen Dun Laoghaire MES system, the MES process and the implementation of MBR improvement opportunities.

• Support training of Electronic Batch Record (EBR) end-users where required.

• Development, review, and update of MES Standard Operating Procedures.

• Accountable for adherence to established timelines and metrics for the change control and Deviation process. This will include providing expertise and support to investigations.

• Contribute and assist with Corporate, FDA, HPRA and other regulatory agencies during audits

• Support to any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment

• Liaison with Amgen MES core-team to troubleshoot and develop new ways of working

• Responsible for providing technical support where required and as directed by Operations leadership

• Other Responsibilities as deemed necessary by Executive Director Patient Supply or Manufacturing Senior Managers.

Basic Qualifications & Relevant Experience preferred:

• Bachelor’s degree in engineering or Science

• 5+ years years experience in Syringe/Vial aseptic manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology

• Previous experience with MES platforms and MBR delivery, ideally PAS│X.

• Working knowledge of parenteral in pharmaceutical/biotech industries or aseptic processing

• Knowledge of regulation requirements (GMP & EH&S)

• Previous experience in managing and leading teams

• Excellent written and verbal communication skills including facilitation and presentation skills.

• Demonstration of strong leadership, negotiation and influencing skills.

• Ability to deal with complexity and ambiguity.

• Demonstrated ability to lead, motivate, coach and mentor.

• Excellent teamwork skills with the ability to collaborate, communicate and be accountable.