Amgen Mgr Manufacturing in Dun-Laoghaire-Rathdown, Ireland

  • The Shift Manufacturing Manager - will report to the Sr. Manager Manufacturing for PM3/PM2 and will be responsible for the manufacturing teams within this Syringe/Vial filling plants. The successful candidate will have at least five years managerial experience preferably in a pharmaceutical or biotech industry. Will work on a rotating shift basis, leading a manufacturing team.The ideal candidate will have:* Experience of working in syringe/Vial manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology.* The ability to adapt quickly to the demands of syringe/Vial filling.

  • Production Management & Autonomy

  • Accountable for Delivering Results by:

  • Establishing high performance standards, using measurable goals to track progress and continually raising the bar on performance & expectations.

  • Focusing their organization on high impact activities by clearly communicating accountabilities and expectations.

  • Ensuring that all metrics relating to schedule, output, quality, safety and reporting are met during their shift.

  • Ensuring that appropriate staff levels are available at all times to meet targets.

  • Communicating production issues and appropriately escalating issues that may jeopardise manufacturing deliverables.

  • Responsible for Charting the Course by:

  • Conveying a sense of purpose and mission that motivates others.

  • Maintaining direction, balancing the big picture concerns with day-to-day issues.

  • Responsible for being a Role Model by:

  • Living the Amgen Values and setting expectations for others to do so.

  • Demonstrating technical mastery of the job

  • Championing opportunities for change and innovation

  • Accountable for work which is guided by operational and project objectives and with minimal supervision.

  • Manage multiple assignments and processes

  • Independently determine approach to projects

  • Independently develop solutions that are thorough, practical and consistent with functional objectives

  • Support New Product or Process introduction by providing line resources for completion of predetermine project tasks

People Management

  • Manages each individual on the team, using MAP performance management systems, to ensure they meet the required performance standards, addressing issues with individuals where required.

  • Provide training, guidance and coaching to your team

  • Ensure each member of the team has opportunity and support to meet their own development needs.

  • Accountable for ensuring that all staff maintains necessary training qualifications and operate in compliance with SOP's and to GMP standards.

  • Responsible for Developing the Best team by:

  • Building diverse and empowered teams.

  • Providing honest and constructive feedback on an ongoing basis.

  • Championing a positive employee relations climate.

  • Partners and communicates effectively with other departments and support functions to ensure positive working relationships.

  • Extends capabilities by working closely with senior staff / experts within and outside organisation

Compliance/Quality

  • Works in a collaborative manner with other shifts and is involved in investigations, change control issues and the closure of NC's

  • Contribute to and assist with Corporate, FDA, HPRA Auditors and other regulatory bodies during company audits.

  • Ensure the cGMP compliance of the area

  • Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported in a timely manner. Promotes a positive safety culture

Knowledge and Problem Solving

  • Broad knowledge within own speciality area

  • Accountable for enhancing own knowledge through understanding business trends and objectives

  • Knowledge of industry and business principles

  • Understands the core business process and purpose of the functional area in Amgen's commercialisation process

  • Handles diverse scope of issues that require evaluation of a variety of factors including current business trends.

  • Implement, assign, lead or participate in projects and develops own project management techniques

  • Applies analytical skills to evaluate and interpret complex situations / problems using multiple sources of information

  • Anticipates and prevents potential problems

  • Forecasts, models and utilises advanced analytical tools

  • Qualitative information, Quantitative research and Trend data

  • Support planning, developing and maintaining the department budget

  • Responsible for development and accomplishment of departmental goals

  • Able to travel to other locations for training, to support FAT's and to evaluate new equipment.

  • Additional Job Description

Additional Job Description

Basic Qualifications & Relevant Experience preferred:

  • Bachelors degree in Engineering or Science

  • Working knowledge of parenteral pharmaceutical/biotech industries and aseptic processing

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

  • Typically 5+ years' experience in an aseptic pharmaceutical environment.

  • New Technology Introduction (e.g. Automated systems)