Career Category

Process Development

Job Description

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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 Scientist

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What you will do
 

As a member of our team, you will play a crucial role in shaping the analytical lab capabilities and team within the analytical function of Process Development, Amgen Waterford. Your expertise will contribute to the management, growth, and success of the analytical lab on site.

This is a full time, onsite role, emphasizing key input both practically and theoretically to support the requirements of the lab as they arise. The role is hands on combining both elements of lab-based testing and project management.  You will collaborate closely with cross-functional teams within the Process Development department, within the site, QC and Manufacturing, and across the wider organisational network as required.

You will bring a broad expertise in analytical development, method qualification, validation, testing, technological expertise, and data analytics and interpretation to the role. You will implement commercial and development assays into the lab to support upstream and downstream drug substance process development /characterization studies. Additionally, you will support drug product heightened characterization via formulation development, process development and liquid and solid-state characterization studies. You will support commercial and development comparability programs and perform analytical product characterization as well as execution of forced degradation studies. You will assist in the development and optimization of new assays and trouble-shoot existing assays that are being used for release and stability testing of commercial and development products. You will assist in growing the team including the management, cross training, support, mentoring and leadership of the wider team. The ideal candidate should bring a curious mindset and an appetite for learning and collaboration to the role.

Other responsibilities include supporting analytical deviations and CAPAs, authoring and reviewing analytical protocols and reports and authoring the method development, validation, and comparability sections of regulatory dossiers. The candidate will also be heavily involved in maintaining and enforcing our strong commitment to safety.

Responsibilities:

• Contribute to the ongoing management and LCM of the Waterford Process Development lab to ensure all required equipment and instrumentation is installed, maintained, fit for purpose and available for use.
• Lead and contribute to the establishment and qualification of assays required for in-process testing and product quality determination to support upstream and downstream process characterization studies.
• Collaborate with wider operations team members including the quality control function to provide technical support for in-process and release testing of bulk drug substance/product as required.
• Provide data interpretation and perform data analytics, trending and monitoring using statistical methods as appropriate.
• Work closely with vendors as well as Amgen functions such as Procurement, Legal, Finance to maintain lab functionality.
• Contribute to the technical transfer of analytical methods including qualification, validation activities as well as relevant documentation authoring/reviewing.
• Assist with the maintenance of our documentation system to document all lab activities.
  Support general lab equipment maintenance best practices and procedures.
• Actively partake in safety walkdowns, observations and general safety commitments to ensure a safe working environment for all personnel.
• Work collaboratively with the Waterford process development team and the wider stakeholder groups. 
• Execute and report support analytics in support of the process development studies in the laboratory.
• Contribute to a culture of collaboration, participation, respect, and knowledge development among the team. 
• Adhere to all site safety, environmental and industrial hygiene procedures, and practices.

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