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Amgen Process Development Manager - Rare Disease (12 Month FTC) in Dublin, Ireland

LIVE, WIN, THRIVE

At Amgen, your ideas are the first step. We’re on a continued goal of transforming biotech to better understand human diseases and how to fight them. Here’s what it takes: The courage to dive into the challenges most won’t and never forgetting who relies on our success. With our combined perspectives, we can build a better world for patients. Join us and discover purpose through your career.

Role: Process Development Manager – (12-month fixed term contract)

LIVE

What you will do

As a member of our team, you will play a crucial role in advancing scientific and technical knowledge within our organization. Your expertise will contribute to the development, support, and troubleshooting of various biological processes. These processes span from cell line development through upstream and downstream processing.

This is a virtual role , reporting to the Director – Biologics Technical Development, Horizon Therapeutics Ireland , emphasizing interaction with internal departments, operations, Contract Manufacturing Organizations (CMOs), and Contract Research Organizations (CROs). You’ll collaborate closely with cross-functional teams, supporting manufacturing deviations, Corrective and Preventive Actions (CAPAs), and contributing to the authoring and review of technical protocols and reports.

Responsibilities:

Engineering and Technology Support :

  • Provide technical support for the development, technology transfer, and commercial production of Drug Substance.

  • Collaborate with contractors to collect and trend process, analytical, and stability data, ensuring thorough investigation of any discrepancies.

Technology Transfer and Collaboration :

  • Support internal and external Product/Process Development and Manufacturing functions.

  • Facilitate the smooth transfer of technologies and products between sites.

Cross-Functional Interaction :

  • Collaborate with Quality Assurance (QA), Manufacturing, Regulatory, and Project Management (PM) teams.

  • Manage multiple concurrent projects, always seeking opportunities to apply cutting-edge technologies and streamline processes.

Be part of our team

We are a team of agile, out-of-the-box thinkers who are inspired to do more because we know we are part of something bigger. Striving to build meaningful careers at a company whose values we share because when we live up to our potential, we help patients live up to theirs.

WIN

What we expect of you

To excel in this role, you should possess the following qualifications and skills:

  • Experience with Bioreactors and Upstream Technologies : You’ll need hands-on experience working with bioreactors and fermenters, particularly in the context of cell-line and process optimization.

  • Deep Understanding of Biological Processes : A solid grasp of biological processes, including critical process parameters, impurity generation and removal, and equipment attributes, is essential. This knowledge will support development projects and technology transfers.

  • Process Development and Manufacturing Knowledge : Familiarity with process development and the manufacture of biological products using microbial and/or mammalian expression systems is crucial. Whether at lab-scale or manufacturing scale, your expertise in this area will be valuable.

  • Analytical Techniques : Proficiency in analytical techniques related to biologics is desirable.

  • Technical Expertise in Technology Transfer : Demonstrating your ability to transfer processes effectively between different scales is important.

  • Track Record of Timely Results : You should have a proven track record of delivering consistent results within project timelines.

  • Educational Background : A bachelor’s degree in engineering or an applied science is required, and an advanced degree is preferred.

  • Pharmaceutical Development Experience : With over five years of relevant experience in pharmaceutical development and manufacturing of biologics, you’ll bring valuable insights to the team.

In addition to the qualifications, consider the following personal attributes:

  • Flexibility : As part of an agile and growing organization, adaptability to new acquisitions and market demands is crucial.

  • Technical Creativity and Innovation : Your ability to think creatively and innovate, both independently and collaboratively, will contribute to the team’s success.

  • Problem-Solving Skills : Recognizing areas for improvement and proactively proposing change programs demonstrates your problem-solving capabilities.

  • International travel of up to about 1-2 weeks may be periodically required.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization

  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

  • Flexible working from home and remote options available for specific roles within Ireland

APPLY NOW

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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