QC Biochemists

Astellas; Ireland; On-site; EUR 55,000 - 75,000; Full time

Job summary

Astellas invites applications for a QC Biochemist to support operations with testing across receipt, in-process, finished and stability samples. You will contribute to method validation and technical transfer, manage documentation, and train staff in QC laboratories at the Tralee plant. The role emphasizes compliance with GLP, GMP, and safety standards.

The role requires a B.S. degree in Chemistry or Microbiology and relevant QC laboratory experience, with an on-site work arrangement and

Qualifications

• B.S. degree in Chemistry/Microbiology with relevant industry experience in a Quality Control lab.

Responsibilities

• Carry out all tasks in accordance with Good Laboratory Practices and Good Manufacturing Practices.
• Compliance with all safety requirements in the laboratory and wider facility.
• Analytical technical transfer of quality control methods and qualification of Pharmacopeial methods.
• Qualification on laboratory instrumentation.
• Responsible for product testing and trend reports and related activities.
• Be a trainer for biochemical testing processes in the quality control laboratory.
• Instrument troubleshooting, and procedure/report writing.
• Receive manufacturing samples for QC analysis and dispatch to contract labs.

Education

B.S. degree in Chemistry/Microbiology

Job description

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

• This position is onsite in Tralee

Working Hours

• Willing to work additional hours as required by the business

Purpose and Scope

The QC Biochemist will be responsible for supporting operations through completion of all testing required e.g., receipt, in-process, finished and stability product testing, report writing, writing procedures, management of systems and training. The role will also have responsibility for tasks associated with analytical method validation (technical transfer and pharmacopeial method transfer/ validation).
This work schedule is subject to change to support business operations. The position will play an important role in the QC laboratories in the Tralee plant.

Role and Responsibilities

• Carry out all tasks in accordance with Good Laboratory Practices and Good Manufacturing Practices.
• Compliance with all safety requirements associated with working in the laboratory and wider facility.
• Analytical technical transfer of quality control methods from existing facilities & qualification of Pharmacopeial methods in the laboratory.
• Qualifications on laboratory instrumentation.
• Responsible for product testing and trend reports and all activities that facilitate those tasks.
• Be a Trainer for biochemical testing processes in the quality control laboratory.
• Instrument troubleshooting, and procedure/report writing.
• Receive manufacturing samples for QC analysis, ship samples to the contract labs testing
• Author and update Laboratory policies and procedures.
• Own incident reports, non-conformances, change controls, CAPAs and OOS investigations.
• Establish & update laboratory procedures that detail data trending including Continuous Process Verification.
• Document results and peer review results in LIMS..
• Participate and own technical projects for QC process improvement and implementation.
• Represent QC in cross functional meetings and provide support/feedback for microbial quality/contamination control of the facility.
• Operate all tasks in a cost-efficient manner.

Essential Qualifications

• B.S. degree in Chemistry/Microbiology with relevant industry experience in a Quality Control lab.

Benefits

Careers | Astellas

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organisational Values and Behaviours

Values: Integrity, Innovation and Impact sit at the heart of what we do.

Behaviors: We come together as 'One Astellas' , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.

Our Organisational Values and Behaviours

Integrity Innovation Impact One Astellas Accountability Courage Sense of Urgency Outcome Focus

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.