Amgen Manufacturing Manager - FTC in Dublin, Ireland
The Manufacturing Manager (NPI/ LCM and Sustainment Projects) – will report to the Manufacturing Director and will be responsible for the manufacturing product leads and technical writer teams. The successful candidate will have at least five to ten years of experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading complex manufacturing projects.
The ideal candidate will have:
Experience of working in syringe/Vial manufacturing operations
Experience in a new product / process introduction or have a demonstrated capacity to learn quickly and adapt to new technology.
The ability to adapt quickly to the demands of product introduction changing timelines.
- Hold primary responsibility for delivering robust, reliable and efficient manufacturing processes
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.
Ensuring that appropriate staff levels are available at all times to meet targets.
Communicating issues and promptly 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 resources for completion of predetermine project tasks
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.
Leading and supporting OJT activities for staff proficiency
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
Works in a collaborative manner with other functions to ensure robust investigations, change controls and timely closure of deviations as required
Contribute to and assist with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
Ensure the cGMP and CFR 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
Basic Qualifications & Relevant Experience preferred:
Bachelors degree in Engineering or Science
Working knowledge of parenteral in pharmaceutical/biotech industries or aseptic processing
Knowledge of regulation requirements (GMP & EH&S)
Typically 5 – 10 years experience in an aseptic pharmaceutical environment.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.