As QC Bioassay Senior Scientist, you will be responsible for carrying out tasks and projects related to raw material, utility, in process, release and stability testing of biotechnology products as required by Good Manufacturing Practice (GMP). The site is focused on start-up activities involving commissioning and qualification aligned with project timelines. As part of the project the role will evolve based on project timelines.
Organisation Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. 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, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Department Description
As QC Bioassay Senior Scientist, you’ll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role, you’ll be reporting to the QC Associate Director for Bioassay & Biochemical Assay.
Essential Duties & Responsibilities
- Key member of the QC Team in Dundalk. Will support execution of the strategy and business planning processes, ensuring cross-functional collaboration.
- Achieve a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of biotechnology products.
- Ensure that all testing is completed, reviewed and approved within agreed turnaround times.
- Ensure QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
- Train other QC analysts and Manufacturing personnel in laboratory methods and procedures when required.
- Write/update and review TMs, SOPs and WIs as required.
- Write and review invalid assays, non-conformances and deviations as required.
- Initiate and drive change controls to completion to implement process improvements.
- Actively participates in JBIL lean initiatives such as Kaizen, 5S and Gemba.
- Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Associate Director for Bioassay & Biochemical Assay.
- Potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role
Specific testing experience required:
- Initiation and Maintenance of Mammalian Cell Lines
- Cell Culture Based Bioactivity Testing
- ELIZA Testing
- qPCR Testing
- Bioburden
- Endotoxin
- Environmental Monitoring
- Microbial Identification
Technical Competencies
- Experience working in a QC function in a ‘greenfield’ context of similar size and scale is ideal.
- Expertise in the release of GMP materials and participant in QC activities, such as method transfer, validation etc.
Experience
- More than 8 years’ experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.
- Previous experience managing and leading a small team would be advantageous.
- Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required
- Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project is required
- Management/supervision of personnel with particular attention to schedules and shifting priorities is desirable.
- Previous experience working in a CMO is an advantage.
Knowledge
- Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory
- Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.
Qualifications
- University degree in related science/quality discipline required.
Behavioural Competencies
- Strong leadership competencies with demonstrated management skills
- Excellent interpersonal, verbal, and written communication skills
- Able to think critically and demonstrate troubleshooting and problem solving skills
- Self-starter and self-motivated; organized with good attention to detail
- Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities
- Results oriented, with the ability to manage multiple priorities in a short period of time.
- Collaborative and inclusive approach to work and your colleagues.
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!
Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/ or contact us via [email protected]
WuXi Biologics is an equal opportunities employer.
