As QC Bioassay/Biochemical Assay Scientist you 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.
Department Description
As QC Biochemical Assay Scientist, you’ll be joining an organization 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 Bioassay Team Lead / QC Biochemical Assay Team Lead.
Your 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
qPCR
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. Initiate and drive change controls to completion to implement process improvements.
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 KPI’s, 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 non-conformance, 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 cGMP 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 WuXi 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 WuXi corporate core values and PROUD culture.
Your Profile: The ideal candidate for this position will have the following:
Education
Third Level BSc Degree in related science/quality discipline required
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 qPCR methods is desirable
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.
Personal skills:
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 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.
Strategy
Communication
Leadership
Pay
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