About WuXi Biologics
WuXi Biologics is a world-class biologics services provider from discovery, through to commercialization, with global clients in the biopharmaceutical and healthcare industries.
Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.
The company has sites/offices in China, US, EU, Asia and Israel. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Job Description
QC Separations Team Lead
You will lead a range of technical projects and activities in the QC Separations group at WuXi Biologics.
The site is focused on start-up activities involving commissioning and qualification aligned with project timelines.
As part of the project, your role will evolve based on project timelines.
Your Responsibilities
1. You will be a key member of the QC Team in Dundalk.
2. You will support execution of the strategy and business planning processes, ensuring cross-functional collaboration.
3. You will support the design, construction, and commissioning of the new facility for the production of drug substance.
4. You will develop a Biologics QC separations product-testing team (HPLC, CE, and cIEF) including planning, recruiting/hiring, coaching/mentoring, and training.
5. You will provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations.
6. You will communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations.
7. You will lead and manage a team of QC Separation Scientists and Associate Scientists, providing guidance, performance management, training plans, and direct one-to-one interactions.
8. You will serve as a technical expert supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, and CAPAs.
9. You will develop and maintain a high level of scientific achievements for the company.
10. You will be a point of contact for project coordination, including email and client meetings.
11. You will seek opportunities for continuous process improvements/improved operational excellence.
12. You will ensure that tasks associated with start-up and routine operations are carried out in a safe manner.
13. You will support Risk Assessments for projects and business innovation initiatives from a Separations perspective.
Your Profile
* You should have experience working in a QC function in a greenfield context of similar size and scale.
* You should have previous experience handling regulatory inspections from FDA, EMA, etc., and GMP audits from clients, as well as internal Quality Assurance.
* You should have technical expertise in tech transfer, validation, and troubleshooting Biologics product-testing methods, including HPLC, CE, and cIEF to support QC release and stability testing in a GMP-environment according to USP, EP, and ChP requirements.
* You should have more than 8 years of experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field.
* You should have experience working in the Biologics industry.
* You should have previous experience managing and leading a small team.
* You should have experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems.
* You should have experience with Microsoft Word, Excel, Powerpoint, Visio, and Project.
* You should have strong leadership competencies with demonstrated management skills.
* You should have excellent interpersonal, verbal, and written communication skills.
* You should be able to think critically and demonstrate troubleshooting and problem-solving skills.
* You should be a self-starter and self-motivated, organized with good attention to detail.
* You should be comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
* You should be results-oriented, with the ability to manage multiple priorities in a short period of time.