Associate Scientist Our client is looking for a Associate Scientist to join its team. The team is based both in Slough and Braine and is responsible for developing processes – scale up and piloting of the processes (cell-culture processes – focused on the upstream side of the process). One important aspect is harvesting – once the cells are grown in the bioreactor, and they get them to express the product, the team has to crude purification to remove cells from the product. The type of cells are CHO cells. Another aspect is understanding the scaleup and the transfer to the next scale of the manufacturing in the BPP biopilot (GMP facility).
In short, growing cells, developing the process, keeping them healthy and getting them to express the biologic molecule that is then purified and eventually reaches the patient.
Working with: • Benchtop bioreactors systems, such as Amba systems, Sartorius, • Larger scale piloting systems • single-use bioreactors • shake flasks, • anything on which cell process can be run
What are the responsibilities? The position is primarily lab-based: – A mix of documentation. – Preparing the protocol and the documents. – Preparing the experimental designs and preparing the experiments. – Making buffers – Preparing meetings. – Building bioreactor vessels – Sterilizing equipment – Running the bioreactor – Keeping the cells nice and healthy throughout the whole process – Monitoring, measuring, taking samples, recovering the product – Doing harvest and clarification – Working with colleagues from other departments. Experience and Knowledge requirement Must have – Process development experience – Knowledge of cell culture and bioreactor processes (any scale, pilot scale preferably) – Experience with benchtop bioreactors systems, such as Amba systems, Sartorius, larger scale piloting systems, single-use bioreactors, shake flasks, aseptic techniques, etc. – Minimum 2 years of experience – Fully fluent in English, French is a nice to have
Nice to have – Knowledge/experience with harvesting and clarifying processes – clarification, centrifugation, centrifuge operations, filtration – Experience with antibody expression, recombinant protein expression – GMP experience
Our offer? Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
R&D clinical Contracting – Braine l’Alleud Our client is looking for a profile to fill a position in R&D clinical development. The role involves clinical studies in F1 and F2.
What are the responsibilities? • Activities related to the design, and everything related to the analytical development. • Taking the lead on protocols studies
Experience and Knowledge requirement • Proven project management skills • Experience in medical monitor for vaccines studies • Degree or background in the medical field or proven experience • Nice to have: clinical method development plan management • Fully fluent in English both written and spoken
Our offer? Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Drug Product Expert Contracting – Wavre Our client is looking for a Drug Product Expert to join its team. The role involves protocols related activities and communication with stakeholders.
What are the responsibilities? • Activities related to protocols: aligning to a protocol and reviewing protocols, experiments, etc • Communication with stakeholders both internal and external • Interaction with the QA and RA • DP development – development of small molecules, from the first studies to scale up.
Experience and Knowledge requirement Must have • Experience in the pharmaceutical industry • Knowledge of GMP • Fully fluent in English both written and spoken • Proven experience in DP on small molecules
Nice to have • Proven experience in project lead experience • Dosing for injectables • Knowledge of tablet manufacturing
Our offer? Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Sites and Infrastructures Partner Our client is looking for a Sites and infrastructure Partner to join its team. The role Sites and infrastructure Business Engineering Partners serve as the central point of contact and a robust bridge connecting the Business area, Engineering, and Project Leaders for various facilities infrastructure aspects (such as buildings, roads, parking, landscaping….). The role includes:
Strategic Perspective: Consolidate the overall technical perspective of thebusiness area.
Budget and Feasibility: Accountable for delivering feasibility and design studies.within the budget for the 10-year plan.
CAPEX Coordination
Engineering Support: Sites and infrastructure Business Engineering Partnerscoach and mentor Engineering Managers, ensuring strong technical deliverables forCAPEX Projects.
Resource Allocation
What are the responsibilities?
Understanding Customer Needs:
Gather and comprehend requirements from customers.
Assist customers in articulating their needs to create a GP0 (General
Proposal).
Scenario Development:
Think creatively and prepare various scenarios.
Present these scenarios to stakeholders.
Project Initiation (GP0 Approval)
Support the Sponsor or Idea Owner in launching the project.
Collaborate with the Technical Engineering Team to identify the Project
Leader (PL) and establish the team structure for GP1 (Detailed Proposal).
Drive the project toward achieving GP1.
Coach the Project Leader on following the methodology.
Participate in Project Steering Committee (SteerCo) meetings.
Connecting Customers and Global Engineering:
Serve as the liaison between customers and the Global Engineering
structure.
Communicate customer requests to the engineering team.
Assist the engineering team in resource allocation, technology planning, and
high-level resource needs.
Relay project-related issues from Engineering to customers (Global
information).
Monitor and facilitate the handover process.
Experience and Knowledge requirement
Minimum 5 years in Infrastructure projects like Project Leader or Team Manager
Minimum 1 years within chemical, pharmaceutical or biotech company with minimum technical background (process and utilities).
People management with a minimum of 2 years in a Production/engineering environment as supervisor or manager.
Project management with a minimum of 5 capital projects succefully delivered and experience in capital project management up to min 10 mioEUR.
Experience in risk management (and related specific tools (FMEA, HAZOP)
Experience in capital and asset management is an asset.
Experience in Masterplan building
Fully fluent in English and French
Our offer? Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We’ll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Construction Safety Coordinator – Senior The mission The construction EHS coordinator shall be a competent construction professional, responsible for checking that the project construction activities are executed safely in accordance with the company’s requirements. What are the responsibilities? • coordinate construction activities and liaise with the Host Site EHS team • review safe methods of working ahead of work starting • lead daily safe work planning sessions e.g. SPA, RAMS, PTW • participate in daily prestart workforce safety briefings • participate in safety meetings and lead daily safety walks of the site • participate in toolbox talks • assist in incident investigation • induct / orientate the workers • identify and control new workers • identify general and specific safety hazards to the workers • inspect and conduct safety audits of tasks and safe systems / processes • ensure that all incidents are reported • participate in incident investigations • ensure workers only carry out tasks for which they are trained and qualified • ensure risk assessments and method statements are in place and in use • encourage and participate in the behavioural safety system • intervene and correct any unsafe conditions • participate in safety meetings • ensure good housekeeping and organised tidiness (5S) at all times
Experience and Knowledge requirement • Experince in construction management of medium and large capital projects • EHS experience Soft Skills: • Project and people management skills with thorough knowledge of construction • Communication and collaboration skills
Education, Methodology & Certification Requirements; • University or college training in engineering or EHS • Formal safety professional certification
ICT Skills (software, operating systems, hardware, etc.); MS Office
Language Proficiency Requirements: English – Business French – Fluent
Our offer? Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Our partner is looking for a Global Trade Compliance Coordinator to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Today it's a small team and they want to strengthen the team to help keep up to date with customs and export control responsibilities.
Several subjects are covered and they are flexible to push/distribute one project or another depending on the strengths of each member of the team (based on their experience).
Typical day :
See what new requests have come in concerning customs or expert examination.
Do research.
Be flexible and know how to change subject as soon as something new comes in.
Who are you ?
ENG is a must have and FR nice to have
Ability to handle several cases at the same time. You absolutely have to be organized for this role.
Ability to handle pressure.
Knowledge and experience in either customs or export control (both are ideal).
Know how to use Excel
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
CSV EXPERT Contracting – Braine l’Alleud The mission: New MES projects for both manufacturing & Lab’s scope – the goal is to support the activities creation of Test script in Opcenter or XFP and MES for Siemens and to support the validation of IT applications in the labs (Empower, LIMS, ELN). The focus is on Manufacturing (MES) like Siemens Opcenter, but there is a potential evolution to Laboratory and Industrial. The mission includes Test creation, execution monitoring and GMP/GDP projects.
What are the responsibilities? • Create, Test script and review execution in QALM • Creation of all documents in SourceCD based on the Source CD procedures and on the validation approach (deliverable list) approved by a UCB IT Compliance Lead • Support Medior/Senior to Review project test execution review in QALM • Create / Update IT Validation template
Experience and Knowledge requirement Must-haves: • Minimum 3 to 5 years of experience • Experience required in CSV, GAMP5, with a minimum of 1.5-3 Years of experience in CSV • Fluent in English
Nice-to-haves: • QALM • LIMS, Empower, ELN • French is a big plus (business is French-speaking)
Our offer? Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We’ll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Industrial Lead Analytical (ILA) Associate The scope of the position is global within the entire Supply & Technical Solutions (S&TS) network of the Company. The role is focused on supporting, from an operational and project execution standpoint, the Analytical Industrial Lead of commercial products, from late phase development (for commercial readiness) to the end of the life cycle of products. What are the responsibilities? • Providing support and expertise to specific projects led by your team or stakeholders (e.g. implementation of a new regulations, coordination of stability studies to support a process change, support submission readiness for various geographies …) • Implementing analytical life cycle plans or integrated analytical solutions through project management • Being responsible for one or more cross-products activities or business processes (in full or a part of it) within the remit of your department • Supporting ILAs for operational activities within the remit of the department. • Connect with people to develop and maintain interfaces with operations (e.g. QC laboratories, CMO, CLO) • Use your project management skills to implement decisions, plans and solutions • Show-off your energy and dynamism to evolve in a complex matrix environment • Work in autonomy with a problem solving & pragmatic mindset. • Work on several projects in parallel with agility and smooth communication to support members of the team
Experience and Knowledge requirement • Proven project management skills including planning, monitoring, issue resolution, risk mitigation and reporting • Exposure to GMP, Regulatory Affairs and Quality applied to analytical • Fluent in English and French • Customer and results oriented • Ability to summarize challenges and issues to management • Knowledge of basic Microsoft tools (Teams, Excel, powerpoint,..) • Ability to review data and documentation with a scientific eye • Knowledge of pharmacopeias and Physchem methods is a plus
Our offer ? Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Our partner is looking for a Computer System Validation to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Writing, reviewing and approving of validation plans and validation summary reports
Reviewing and approving of Technical Change Description
Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports, …
Reviewing of CVS specific SOP’S and Templates
Ensure the proper execution of the qualification and validation activities with respect of the company validation methodology
Who are you ?
University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
You speak French and English
Certification in computer system validation or equivalent is a plus.
Experience in a computer systems validation role
CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
The mission New MES projects for both manufacturing & Labs scope – the goal is to support the activities creation of Test script in Opcenter or XFP and MES for Siemens and to support the validation of IT applications in the labs (Empower, LIMS, ELN)
Day-to-day activities • Create, Test script and review execution in QALM • Creation of all documents in SourceCD based on the Source CD procedures and on the validation approach (deliverable list) approved by a the IT Compliance Lead • Support Medior/Senior to Review project test execution review in QALM • Create / Update IT Validation template
Profile Must-haves: – Experience required – CSV, GAMP5 a minimum of 1.5-3 Years of experience in CSV – English
Nice-to-haves: – QALM – LIMS, Empower, ELN – French is a big plus (business is French-speaking)
Minimum number of years of experience: 3-5 years
Our offer ? Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
