Process Validation Scientist for Biologics DP.

For our client, an international pharma company in Schaffhausen, we are looking for a Process Validation Scientist/Engineer for Biologics DP

The candidate should have expertise in ICH quality guidelines and late-stage biologic DP manufacturing. Hands-on experience in other areas such as Quality, R&D and Manufacturing Operation is highly desirable.



General Information:
 

• Start date: ASAP / to be discussed
• Duration: 1 year contract
• Extension: possible, to be discussed
• Workplace: Schaffhausen
• Workload: 100%
• Home office: possible in a hybrid model
• Travel: Domestic ~25% of time based on role and specific business goals

Tasks & 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.

Must Haves:
 

• 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 with 8+ years of experience.
• Fluent in written and spoken English.
• 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.