Biologics Development Scientist Leader
vor 18 Stunden
Randstad is seeking a Process Validation Scientist for Biologics DP to join our team in Schaffhausen. As a key member of our organization, you will play a crucial role in ensuring the quality and compliance of our biologic products.
Job DescriptionWe are looking for a highly skilled and experienced professional to lead our process validation efforts for biologics DP. The ideal candidate will have a strong background in ICH quality guidelines and late-stage biologic DP manufacturing. Additionally, they should have hands-on experience in areas such as Quality, R&D, and Manufacturing Operations.
- 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.
The successful candidate will possess a degree in a relevant field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with at least 4 years of experience in biopharmaceuticals or equivalent. They must be fluent in written and spoken English and have a proven track record in areas such as DP comparability, Equipment qualification, Pharmaceutical process development, Technology transfer, and Process validation. Strong leadership skills, including ability to foster team productivity and cohesiveness, and to work collaboratively to execute, deliver and get results through matrix teams, are also essential.
Influencing others to accept new ideas, approaches or concepts or gaining alignment on divergent issues is critical. Demonstrated experience in technology transfers projects, partnering with R&D and commercial supply to improve fit for plant and commercialization of new products into the supply chain, personal and interpersonal skills/leadership skills, planning and logistics skills capable of effective integration of deliverables at the manufacturing site level, 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, and can-do mentality: takes initiative, creates a result-oriented working spirit in his/her team.
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