Process Validation Scientist for Biologics DP
vor 20 Stunden
Job Type: Contract
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
- 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.
- Influence others to accept new ideas, approaches, or concepts or gain alignment on divergent issues.
- 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 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 transfer 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 and 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 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 and 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.
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