The role
03We are looking for a Manufacturing Science and Technology Expert - Drug Product (m/f/d) - 80% -100%. This role is important for ensuring successful technology transfers, maintaining GMP compliance, and driving continuous improvement. If you're a proactive problem-solver with a strong background in manufacturing science and technology, we want to hear from you. The position is based in Visp, Switzerland. Relocation is available for a successful candidate and their family, if needed.
01Manage and lead QC projects from initiation to completion, defining project scope, timelines, resources, deliverables, and reporting project progress while escalating issues when necessary.
02Perform, oversee, and coordinate chemical and physical testing of raw materials, in-process samples, and finished products using analytical techniques such as HPLC, GC, UV/Vis, KF, and FTIR, ensuring data integrity, testing compliance, and timely support of project and release activities.
03Develop, validate, and transfer chromatographic analytical methods in accordance with ICH guidelines, regulatory requirements, and applicable quality standards.
04Troubleshoot analytical instrumentation and methods, implementing corrective and preventive actions as required.
05Ensure compliance with GMP/cGMP requirements, regulatory expectations, and internal quality standards across all QC activities.
06Initiate, manage, and close change controls, deviations, OOS/OOT/OOE investigations, and laboratory investigations, including root cause analysis, impact assessment, CAPA implementation, and thorough documentation to ensure timely resolution.
07Document and review analytical results, project activities, and investigation outcomes in accordance with GMP requirements.
08Prepare, author, review, and approve technical documents, including method validation and method transfer protocols and reports, SOPs, quality instructions, and other QC-related cGMP documentation.
09Act as the primary QC point of contact for assigned customer projects, ensuring effective communication and stakeholder alignment.
10Serve as the interface between QC personnel and external contract laboratories, coordinating testing activities and resolving technical issues as required.
11Collaborate effectively with cross-functional teams, including R&D, Production, Quality Assurance, and external partners, to ensure successful project execution and regulatory compliance.
12Provide technical expertise, coaching, and guidance to junior chemists and other team members.
13Participate in internal and external audits, address audit observations, and support the implementation of continuous improvement initiatives.
