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Biologics Purification and Validation Expert
CTCZurich Metropolitan Area, CHIl y a plus de 30 jours
Description de posteRelevant working / residency permit or Swiss / EU-Citizenship required. Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals or bachelor’s degree + 8 years of experience. Proven track record in in at least three of these areas : DP comparability Equipment qualification Pharmaceutical process development Technology transfer Process validation Demonstrated technical competency and experience with biologic DPs. Demonstrated experience in technology transfers projects. Partnering with R&D and commercial supply to improve the fit for plant and commercialization of new products into the supply chain. Personal and interpersonal skills / Leadership skills Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites. Planning and logistics skills capable of effective integration of deliverables at the manufacturing site level. Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams. Ability to influence and lead peers, superiors, and external partners, including interaction with senior management. Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly. Ability to manage complexity and change. Motivated, self-starter able to work independently with demonstrated problem solving skills. Drives for innovation and change to ensure competitiveness. Can-do mentality : takes initiative, creates a result-oriented working spirit in his / her team.
Main Responsibilities :
- Support complex technology transfers with a focus on right-first-time execution and risk management.
- Translate late-stage regulatory DP manufacturing strategy into tech transfer plan
- Author, review, and approval of technical and regulatory documents (e.g., batch records, validation protocols, control strategy, and reports).
- Support DP Process Performance Qualification and preparation of regulatory reports.
- Support the internal and external teams in qualification of DP manufacturing equipment.
- Perform as SME to identify technical areas for improvement, and supply chain improvement.
- As needed, provide SME input on change management, product impact assessment and implementation of changes to the DP manufacturing processes.
- Influences others to accept new ideas, approaches or concepts or gains alignment on divergent issues.
Qualifications and Experience :