Global QC Labs Associate Application Engineer -Manufacturing Systems

Industry:

Company: Astellas Pharma, Inc.

Job Description

At Astellas, we strive to become a cutting-edge, value-driven life science innovator.This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.

What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.

Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women’s health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.

About Us:

We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 byFierce Pharma.

We are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.

We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way – patient focus, ownership, results, openness and integrity? Then we would love to hear from you.

From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.

Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.

Description:

As a Global QC Labs Associate Application Engineer you will be the Subject Matter Expert. Your tasks are focused on system administration, maintenance, enhancements and facilitate changes to laboratory systems and business processes in a complex Scientific IT landscape In this role, you will work with advanced lab systems such as Chromatography Data Systems (CDS), Scientific Data Management Systems (SDMS), Laboratory Information Management Systems (LIMS), Electronic Lab Notebook (ELN) and other specialized software to ensure proper operation of GxP and non-GxP systems.

Requirements

Responsibilities:

• Be the first point of contact for key users in the QC labs and provide technical support and learn the skills on the job for the laboratory systems.
• Work closely with colleagues in the QC labs and use your skills in a global support team supporting QC labs all over the world while contributing to the digitization and optimization of lab processes
• Be the subject-matter expert for the lab systems during inspections and audits.
• Manage system access and ensure proper operation of GxP and non-GxP lab systems such as LIMS and Empower in close collaboration with the vendors and internal stakeholders
• Attend trainings on lab systems and technologies, and stay up to date with the latest developments in Scientific IT and digital solutions.
• Actively participate in and contribute to various initiatives like process improvements and set up/improve the Scientific IT landscape
• Contribute to the ongoing realization of Value from these lab systems through continuous integration and deployment.
• Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities.
• Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions

Required Qualifications:

• Recent graduate or professional (bachelor’s or master’s degree) with 1 to 2 years’ experience in relevant field such as Biotech, pharmaceutical sciences or Quality Control (QC) lab work
• A strong interest in technology and curious about how IT processes can improve lab environments
• Knowledge of manufacturing processes
• Strong analytical and problem-solving skills
• Ability to work together in a team environment
• Excellent communication skills, both written and verbal (English (or English/Japanese for JP region)
• Agile and adaptable to changing environments
• Have experience understanding and collaborating with business to define epics/user stories/features, as well as conducting impact analysis
• Able to support technical upgrades by conducting impact assessment, addressing any issues, support testing, and document changes per the System Life Cycle (SLC) processes in Astellas
• Mandatory local language to communicate to business QC Labs and Site management

Preferred Qualifications:

• Preferred knowledge in PL/SQL, Python and Power BI
• Experience in developing and configuring with Empower, LIMS Software and QC Lab Solutions

Working Environment:

• This position is hybrid (on-site/remote) and based in Poland/Japan/Ireland/US/Canada
• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.