Engineer III, Product Development
Company
Thermo Fisher Scientific
Location
Manage, Belgium
Type
Full Time
Job Description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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 Senior Scientist.
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 handle customer project for our department and own the development and implementation strategies of the projects within the operations. Your technical expertise and collaborative thinking will be essential for the preparation, production, delivery, follow-up and improvements of customer projects.
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You will be responsible for all USP aspects of our customer projects, and the key point of contact for the operations (technical and scientific activities), by:
- Ensuring the robustness of the upstream development strategy for client projects.
- Designing and implementing technical studies, analyzing and communicating results through protocols, study reports, teleconferences, and customer meetings, while adhering to the principles of QbD and cGMP.
- Relaying and driving actions from customer and internal meetings to the USP team.
Coordinating and planning the technical transfer of upstream processes to GMP entities, working closely with USP Managers and Scientists/Line managers.
- Providing proficiency in drafting development protocols and reports, scale-up or process characterization, and ensuring technical and quality monitoring of clinical and commercial batches (Data, Deviations, technical CAPA).
Development of R&D activities
As the Senior Scientist, you are able to identify, propose and implement innovative solutions that bring significant benefits to the operations, by participating to manufacturing projects, in collaboration with relevant team members. You are also the referent for the USP GMP aspects and quality systems.
Giving support by:
- Being the reference in the field of investigations linked to Deviations, or technical incidents on the equipment/processes used.
- Ensuring the traceability of operations carried out within the manufacturing areas.
- Safeguarding the quality compliance by the operational team (SOPs and GMP/GLP standards).
- Promoting the 5S policy with your team in our work environment.
- Proposing improvements, or innovative alternatives.
- Motivating all the resources to improve the efficiency and productivity of the operations aiming for right first time and on-time delivery mentality.
Role complexity
Apply your technical and operational expertise in different areas of activity, including:
- Proficiency in Cell culture techniques as adhesion or suspension (T-flasks, Cell Factories, Bioreactors, etc.) for viral production purposes, plasmid transfection and viral infection methods
- Pragmatism in applying GMP in a phase-specific manner
- Strong ability to work in aseptic processing (BSL2 or BSC (grade A/B)
- Excellent organizational skills to efficiently prioritize and coordinate activities. Apply your scientific analysis and synthesis skills to make significant improvements.
- Clear and efficient communication to collaborate with the customer and within teams. Experience working in multi-functional matrices.
Education, knowledge and experience
To excel in this opportunity, you must possess proven experience and have a strong desire to thrive in a collaborative environment.
In details, the following qualifications are required:
a PhD, Master, or Bachelor's degree in Biology, Biotechnology, or Bioengineering, or possess an equivalent level of experience. Equivalent experience will be taken into account. Fluency in English (oral and written) is a requirement, along with proficiency in MS Office suite, MS project, and SAP. Basics in statistics and DoE is a plus. Expertise in GMP, GDP, and the use of Quality systems is expected.
Preference will be given to candidates with experience (>4 years) in pharmaceutical area, and particularly with extensive knowledge in cell culture processes in a R&D and GMP manufacturing environments.
Employee benefits : attractive salary ranges and advantages package based on experience, including company car and fuel card. Homeworking permitted.
At Thermo Fisher Scientific Inc., we are engaging to fostering 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.
Date Posted
10/08/2024
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