Company description: Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) 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.
The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.
Job description: As QC Bioassay/Biochemical Assay Scientist, will be part of various technical projects and activities in the QC Bioassay/ QC Biochemical Assay Laboratories.
The site is focused on a variety of activities involving commission, qualification, validation and GMP testing work, and potential candidates are required to be flexible in this regard.
This also means that 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.
This successful candidate will perform duties across both the QC Bioassay and QC Biochemical Assay Laboratories, but with an emphasis on one.
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In this role, youll be reporting to the QC Bioassay/Biochemical Assay Team Lead.
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Essential Duties & Responsibilities Perform analytical method transfer, validation and GMP routine analysis, including but not limited to: Cell Based Bioassays (Potency) Chromogenic Assays Enzyme Activity Assays ELISA q PCR Western Blot Perform Cell Culture techniques including cell banking, cell revivals, and routine passaging of adherent and suspension lines.
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 Drug Substance testing and release.
Ensure the tasks associated with routine operations of a QC Bioassay/Biochemistry laboratory are carried out in a safe manner.
Participate in QC risk assessments, including Quality risk assessment and EHS risk assessment.
Development of training material for the QC Bioassay/Biochemistry Laboratory personnel.
Act as a trainer for analytical methods and procedures.
Act as designee in absence of QC Bioassay/Biochemical Assay Team Lead.
Lab scheduling and planning for routine testing, investigational testing, and projects.
Routine monitoring of laboratory KPIs, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects.
Participate in the laboratory deviation and investigation process such as OOS, OOT and nonconformance, including the implementation of CAPAs and change control.
Identify and prepare required GMP documents such as SOPs, OJTs, protocols, methods, and reports.
Provide effective communication and support project management regarding internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.
Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
Ability to support regulatory inspections from FDA, EMA, etc.
and c GMP audits from clients, as well as internal audits.
Participate in relevant internal and external QC related audit and general site audit readiness.
Ability to work in a team environment and independently as required.
Perform job specific tasks in compliance with applicable Regulations, International Standards, and Wu Xi Biologics Policies and Standard Operating Procedures.
Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
Flexibility to take on additional tasks and responsibilities at the discretion of the Bioassay/Biochemical Assay Team Lead.
Will act as a role model for the QC function and the wider organisation in adherence to the Wu Xi corporate core values and PROUD culture.
Technical Competencies Bioassay / Biochemistry / Immunoassay techniques including Cell Culture, Bioassay, ELISA, Blotting Techniques, q PCR etc.
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Experience Previous experience in a Quality Control / GMP environment.
Experience with Aseptic techniques and operation of a Biosafety Cabinet (BSC).
Experience with cell culture techniques is desirable.
Experience with Bioassay/ Immunoassay/ Enzyme activity methods is desirable.
Experience with q PCR methods is desirable.
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Knowledge Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and / or pharmaceuticals; ICH and GMP guidelines desirable.
Knowledge of routine and non-routine QC testing and techniques and related equipment.
Knowledge of Biosafety requirements, including EPA guidelines on containment and control measures for the use of genetically modified cell lines.
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Qualifications Third Level BSc Degree in related science/quality discipline required.
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Behavioral Competencies Excellent communication, interpersonal and presentation skills.
Ability to think critically and demonstrate troubleshooting and problem-solving skills.
Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
Collaborative and inclusive approach to work and your colleagues.
Excellent problem solving and troubleshooting skills.
Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
Engage cross functionally in conjunction with a site-based team.
Autonomous and a self-starter who will use their initiative to drive actions forward.
Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations?
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Skills: Bioassay Cell based assay Immunoassay Cell Culture ELISA Blotting q PCR Benefits: Bonus Life Assurance Paid Holidays Parking Pension VHI