Senior Scientist in Analytical Method Development (Immunology) Location: Cape Town
Type: Full Time - Permanent
Requirement: Proven AMD experience gained in pharmaceutical industry / biotech or medicine research – please note candidates who have not gained the relevant experience will not be considered
We are seeking a motivated, passionate, confident, proactive, and detail-oriented Senior Scientist specializing in Analytical Method Development with a focus on Immunology or Micro.
Qualification / Experience Requirements, but not limited to: PhD or MSc relevant Science related qualification with minimum 2 to 4 years' experience in Analytical Method Development discipline, experience gained in pharmaceutical industry or biotech or medicine research environment (Micro or Immunology) or equivalent. And competence to assist other Scientists in AMD as and when needed.At least 1 to 2 years supervisory experience in product development or a cGMP environment.Solid understanding of scientific principles governing the production of biologicals or vaccines.Familiarity with quality and regulatory compliance, cGMP (SA, PIC, WHO) and GLP guidelines.Proven experience in successfully facing local quality audits.Exposure to the development and commercialization of pharmaceutical products.Laboratory Administration: Assist with budgeting and cost control, promoting a cost-conscious culture within the department.Service Delivery: Ensure services are provided to all internal and external stakeholders within agreed timelines.Risk Mitigation: Ensure all work adheres to current standards/processes and assist in identifying risks impacting the team.cGMP Compliance: Follow cGMP guidelines and manage Change Controls/NCRs to support QA processes.Site Risk Management: Address facility issues/risks through the proper channels.EHS Compliance: Meet all EHS committee deadlines for assigned actions.Operational Support: Provide guidance, problem-solving, and input to operational departments as required.Documentation: Generate documentation in line with current scientific, GMP, and GDP guidelines.Method Development: Responsible for analytical method development (microbial and immunological).Experimental Design: Plan, execute, problem-solve, and record experimental designs.Project Deliverables: Ensure specified deliverables within projects are met according to timelines.Technology Transfer: Assist with technology transfers from development to manufacturing, including clinical trial material production.Innovation and Improvement: Drive innovation and continuous improvement efforts.Quality Risk Management: Manage deviations, change controls, and CAPAs.Quality Objectives: Promote and drive the achievement of quality objectives.Communication: Ensure timely and effective communication and escalate quality issues to management.Join us to make a significant impact in the field of immunology and vaccine development.Application can be emailed to ****** Required supporting documents to accompany Comprehensive Detailed CV showcasing proven expertise gained: Copy of IDCopies of all required Qualifications, including Matric
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