Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Are you familiar with upstream processes and eager to make a significant impact in our CDMO facility? If so, we have a position that might be of interest for you! We are currently seeking a new collaborator to join our manufacturing team in ThermoFisher as USP Scientist.

Main areas of responsibility

• Development of technical/scientific activities

In this role, you will play a pivotal role in the development, optimization, and scale-up of various cell culture and viral vector processes up to GMP manufacturing. you will have the outstanding opportunity to be part of the exceptional development and scientific activities. Working closely with your N+1/Senior Scientist, you will realize the technical program associated with the project. Your responsibilities will include driving the design of technical programs, developing and improving processes for project realization, and generating process mapping. You will also build article codes and BOM vital for the program, ensuring that all elements like consumables, products, and documentation are in place for successful technical implementation. Additionally, you will write checklists, master batch records, and work instructions related to the project, and ensure their accurate follow-up. Your role will involve practical implementation of critical steps in R&D or clinical batches, working in sterile conditions and in BL2, and prioritizing the traceability of operations. You will coordinate line-clearance in R&D and complete checklists according to good documentary practices. In addition, you will perform in-process control tests such as cell count and bio-profile to supervise the processes, analyze results, and prepare client slides with the mentorship of the Senior Scientist. Your ownership will also include writing technical reports, leading quality systems, ensuring compliance with regulatory requirements, and participating in the transfer of R&D processes to clinical production.

Support activities

• Apply the 5S policy in your team
• Meet and implement applicable safety & bio-security standards
• Ensure compliance with SOPs and GMP/GLP standards
• Attend meetings required to function
• Train team to procedures (theoretical and practical training)
• Propose process improvements

Complexity of the function

• Organizational Skills
• Prepare / prioritize / plan / coordinate the different activities; team spirit
• Technical and operational skills in different areas of activity
• Techniques of cell culture for viral production
• Methods of transfection and infection
• Presentation techniques (power point and synthesis)
• Aseptic working (sub-flow work BSL2)
• Writing skills,
• SAU user,
• Ability to analyse and synthesise science.
• Communication:
• Intra-team interactions, DSP, DevA, Supply chain, Logistics, QA

Knowledge and level of education

To excel in this position, having a Bachelor's or Master's degree in the fields of Biology, Biotechnology, or Bioengineering is preferred. Equivalent experience could be considered. Your expertise in GLP/GMP, GDP, and quality systems implementation will be highly valued. Proficiency in MS Office Suite (Excel, Word, PowerPoint) and SAP will enable you to perform your duties. Additionally, speaking English will be useful for effective communication within the team and across the organization.

Employee benefits : attractive salary ranges and advantages package based on experience. Homeworking is for sure permitted.

At Thermo Fisher Scientific Inc., we are engaging to encouraging an inclusive and collaborative work environment. We are an equal opportunity employer and provide reasonable accommodations/adjustments to individuals with disabilities. Be part of a dynamic, fast-paced company that strives for efficient execution, innovation, and results.