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Manufacturing Manager (MES)

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Amgen

24d ago

  • Job
    Full-time
    Senior Level
  • Engineering
  • Dublin

AI generated summary

  • You should have 5+ years in aseptic manufacturing, MES expertise, a relevant degree, strong leadership skills, and experience in cross-functional teams in the pharma/biotech industry.
  • You will recruit and train personnel, manage resources, ensure safety compliance, develop MES processes, support audits, and collaborate with cross-functional teams for project success.

Requirements

  • 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.
  • 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.

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.

FAQs

What is the main responsibility of the Manufacturing Manager - MES at Amgen Dun Laoghaire?

The main responsibility is to lead a team of MES designers for the generation of Master Batch Records while ensuring compliance with Good Manufacturing Practices and adherence to the Manufacturing Schedule.

What qualifications are preferred for this position?

Preferred qualifications include a Bachelor’s degree in engineering or science, 5+ years of experience in Syringe/Vial aseptic manufacturing operations, experience with MES platforms like PAS-X, and knowledge of regulations such as GMP and EH&S.

Is previous experience in managing teams required for this role?

Yes, previous experience in managing and leading teams is required.

What skills are emphasized for candidates applying for this role?

Candidates should demonstrate strong leadership, negotiation, influencing skills, excellent written and verbal communication skills, and the ability to handle complexity and ambiguity.

Will the Manufacturing Manager be involved in training MES team members?

Yes, the Manufacturing Manager will be responsible for developing the MES team through training and coaching.

What kind of certifications or compliance knowledge is beneficial for this position?

Knowledge of regulation requirements, particularly Good Manufacturing Practices (GMP) and Environment, Health & Safety (EH&S) regulations, is beneficial.

How will the Manufacturing Manager interact with other teams?

The Manufacturing Manager is expected to build collaborative relationships within their own team and across other cross-functional teams.

Are there specific metrics that the Manufacturing Manager is accountable for?

Yes, the Manufacturing Manager is accountable for adherence to established timelines and metrics for the change control and deviation processes.

What experience with MES systems is expected from candidates?

Candidates should have broad technical experience in MES systems and Master Batch Record delivery, ideally with previous work on MES platforms.

Will this role involve interaction with regulatory agencies?

Yes, the Manufacturing Manager will contribute and assist with audits from Corporate, FDA, HPRA, and other regulatory agencies.

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Amgen

#WeareBiotech

Science & Healthcare
Industry
10,001+
Employees
1980
Founded Year

Mission & Purpose

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.