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Biologics QC Team Lead

2 weeks ago


Dundalk, Louth, Ireland WuXi Biologics Ireland Limited Full time
Job Description
As a QC In Process Team Lead, you will play a key role in ensuring the quality and safety of our biologics products. Your responsibilities will include leading a team of scientists and analysts, developing and implementing testing protocols, and collaborating with cross-functional teams to ensure compliance with regulatory requirements. You will also be responsible for managing the start-up and routine operations of the QC In Process group, including commissioning and qualification aligned with project timelines.

About Us
WuXi Biologics Ireland Limited is a world-class biologics services provider with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia, and Israel, and currently employ over 10,000 people.

Your Profile
To be successful in this role, you will need to have at least 8 years of experience working in a Quality Control environment, preferably in the biologics industry. You should have a strong background in analytical chemistry, biochemistry, or molecular biology, and be familiar with GMP guidelines and regulations. Experience with LIMS, Empower, ECM, Master Control, Trackwise, or similar systems is required. Strong leadership competencies, excellent communication skills, and ability to work in a fast-paced environment are essential.

Key Responsibilities
* Lead a team of scientists and analysts in the QC In Process group
* Develop and implement testing protocols for biologics products
* Collaborate with cross-functional teams to ensure compliance with regulatory requirements
* Manage the start-up and routine operations of the QC In Process group
* Ensure compliance with cGMP guidelines and regulations
* Train and develop team members to improve their skills and knowledge