ANALYTICAL VALIDATION AND TRANSFER MANAGER

From Mabxience, a company specialized in the development and manufacture of biosimilar medicines, we are incorporating a QC Manager for our plant in León.Global responsabilitiesThe Analytical Validation and Transfer Manager will play a crucial role in the validation, verification, and transfer of analytical methods within the company. The ideal candidate will have substantial experience in analytical method validation/verification in the pharmaceutical industry and a strong understanding of Compendial and ICH requirements. This position requires basic knowledge of statistics and the ability to manage a diverse portfolio of activities including planning, resource estimation, risk identification, decision making, communication, and team leadership.As QC Analytical Validation and Transfer Manager at Mabxience you work in close collaboration with analytical development scientists and our customers and you are responsible for the project management of our testing services for Biopharma and CMO/CDMO. Specific responsibilitiesOverseeing analytical method validation, verification, and transfer activities in accordance with regulatory guidelines and company standards.Ensuring compliance with Compendial (USP, EP, JP) and ICH requirements for analytical methods.Maintaining a Group of specialists located both in Spain and Argentina, and plan, organize, and manage resources effectively to meet project timelines.Maintaining contacts with customers.Drawing up project plans in consultation with the Manager R&D Analytical Development and the Manager Project Management.Assist in the preparation of quotations for projects.Translate customer demand into protocol and/or work plan.Overall management of the assigned projects including coordination, planning and communication to stakeholders and senior management.Management and execution of various stability studies according to GMP standards and procedures.Review and interpretation of generated data.Conducting investigations into complaints and deviations and reporting this to QA.Taking care of corrective and preventive measures in the event of complaints and deviations.Participate in internal and external audits and regulatory inspections.Requirements and personal skillsEducation: MSc or BSc in analytical chemistry, biochemistry, pharmaceutical Sciences, or a related field.Languages: fluent in spanish and english.Experience (years/area): minimum 5 years of experience in team leading. Strong experience in validation of analytical methods in biotechnology or pharmaceutical industry (required) and CMO/CDMO projects (preferable). Good knowledge of relevant ICH guidelines. Strong project management skills, including planning, resource estimation, and risk management. Excellent communication and interpersonal skills. Detail-oriented with strong problem-solving skills and can run several projects in parallel and working in a flexible way. Travels: open to travel occasionally (Spain – Argentina). Personal skills: independent, self-motivated, enthusiastic, goal-oriented, efficient, and accurate, and enjoy working in a fast-paced environment. We offer a permanent contract to join a growing pharmaceutical company.Life and accident insurance.Free company canteen.Free online training platform.Free online library.Social, physical and emotional well-being platform.mAbxience is committed to equal opportunities. We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.