Global Public Health Biomarker Research Scientist

  • Location: Beerse
  • Type: Contracting
  • Job #17935

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Global Public Health Biomarker Research Scientist

In this role, you will conduct biomarker research related to tropical diseases, such as Dengue fever, in support of the Global Public Health translational science strategy. You will work with the biomarker, discovery and clinical teams and disease area leaders on identifying biomarker needs and implementing biomarker plans to support discovery, translation, and clinical development.

You will engage in the planning, execution, and interpretation of biomarker related efforts in clinical trials, such as assay implementation at CROs, data collection, data QC and supporting analysis activities.

Furthermore, you will participate in a highly collaborative and interactive environment, involving disease related internal and external projects. In this role, you will be a member of the GPH R&D Disease Management Programs team and report to the

Scientific Director Biomarkers.
Location: Beerse

Scope of work:

  • This position primarily includes immunological, cellular, and molecular work within GPH R&D which includes collaboration with commercial and academic laboratories.
  • Your research will be focused on the use of different technologies to assess the host response to infections (such as Dengue virus), and/or on the development of existing and new biomarker measurements and assay strategies related to biomarker application and validation.
  • Your role will include collaboration with Discovery and Clinical Research colleagues to implement biomarker measurements that will inform and improve decision-making for the GPH drug portfolio.
  • You will serve as an assay expert to GPH R&D biomarker leaders and in support of clinical teams.
  • Scientific partner with CROs and external academic research groups. Drive scientific collaborations and projects with external key opinion leaders in the field
  • You will have responsibility for recommending sample volume, acquisition, and handling requirements to operations and clinical teams, and work with the operations team to maintain an up-to-date tracker of available biomarker samples.
  • You will assist with data analysis and interpretation and, with GPH Biomarker Leaders, communicate results to internal and external organizations.
  • You will remain current on the evolving landscape of biomarker technologies and applications and relevant drug mechanisms of action.
  • You will assist in collaborations with academic, industrial consortia, and commercial partners to optimize support of GPH biomarkers.

Who are you?

  • Ph.D. (Pharmacology, Biochemistry, Molecular/Cell Biology, Immunology, Biological Engineering, or related field) with relevant experience focused on host immune response to infections (cellular and/or humoral) and/or experience in the use of different -omics technologies is required.
  • Established scientific achievement as demonstrated by a robust publication record is required.
  • Excellent communication, data analysis and interpretation skills are required.
  • Proven ability to work in a team environment and to lead projects with minimal supervision is required.
  • Excellent organizational skills to support clinical study sample analysis is preferred.
  • Knowledge and experience in tropical diseases and/or viral infections is preferred.
  • Experience in arbovirus research is an asset.
  • Experience in flow cytometry, ELISPOT, and ICS is preferred.
  • Experience in developing and validating immunoassays is preferred.
  • Experience in sample preparation using blood (whole blood, PBMC’s, plasma/serum) and other biofluids is strongly preferred.
  • Experience in working in a project with multiple academic and industry partners is an asset.

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Associate Scientist Infectious Disease Discovery

  • Location: Beerse
  • Type: Contracting
  • Job #17711

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Associate Scientist Infectious Disease Discovery

In this role you will support the ongoing research in the infectious disease TA aimed at the discovery of new antiviral agents for prevention of respiratory virus infection. You work in a small team with the opportunity to interact with other groups in our client’s organization, bridging different stages of the discovery pipeline. You are highly motivated and passionate about performing research and associated laboratory tasks.
Location: Beerse

Scope of work:

  • Evaluation of antiviral activity of newly discovered molecules in virus neutralization assays
  • Respiratory virus and mammalian cell culture
  • Bioanalysis of in vitro and in vivo samples (viral titer and drug concentration analysis)
  • Assist in running viral challenge studies to assess the efficacy of lead molecules. This includes dosing, scoring, weighing, and sampling of animals.

After a period of initial training, it is expected that you will become an independent labbased scientist.

Who are you?

  • MSc. degree or equivalent in virology, immunology, cell biology or related disciplines
  • Experience with virus neutralization assays, molecular biology techniques (RNA extraction, RTqPCR) and/or ligand binding assays is a plus
  • Willingness to work in BSL2-3 environment
  • Detail-oriented, with excellent record-keeping skills
  • Strong organizational skills
  • Excellent interpersonal skills with the ability to interact in constructive and productive ways with other team members
  • FELASA B or C certification to work with laboratory animals, or equivalent would be a plus 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

 

Research & Development Scientist

  • Location: Beerse
  • Type: Contracting
  • Job #17560

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Senior Associate Scientist

Our client is currently looking for a Senior Associate Scientist.

The department you will be working in is responsible for: Method Development, Method Validation, Method Transfer and support for chromatographic, spectroscopic and physicochemical methods.
Location: Beerse

Scope of work:

  • Execute method development, validation and transfer activities on small molecule projects related to lab technology (NIR/Raman) with focus on Polymorphism.
  • Perform statistical data analysis and building chemometric models.
  • Develop and implement on-/in-line process analytical tools (e.g. Raman, NIR, Laser Diffraction,…) to monitor and control critical process parameters of pharmaceutical processes during batch process and Continuous Manufacturing.
  • Execute data review
  • Author and review protocols and reports regarding method development, method validation and method transfer
  • Report results to teams and management.
  • Ensure high scientific quality standards for experiments and take on responsibility for these experiments.
  • Comply with regulatory, GMP and safety rules
  • Work in a multidisciplinary team

Who are you?

  • You hold a Master degree in Analytical Chemistry, Pharmaceutical Technology or a related science with a minimum of 5 years of experience in a Pharmaceutical Company.
  • You have good knowledge of GMP.
  • Expertise in various spectroscopic techniques (NIR, Raman, UV and IR) for application in analytical chemistry is preferred.
  • Knowledge of statistical data analyses and chemometrics is preferred.
  • Knowledge and/or experience with pharmaceutical processes (granulation, blending, spray drying, coating, …) is beneficial. 
  • You have a good knowledge of Dutch and English, both spoken and written.

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

 

Are you interested? Apply now with your cv!

Project Manager Lab Systems

  • Location: Beerse
  • Type: Contracting
  • Job #17531

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Project Manager Lab Systems

Our client is recruiting for a Project Manager Lab Systems, reporting into QC Operations.

Scope of work:

The position will support the deployment and maintenance of the digitalization/automation project for our client’s labs (iLABs). The laboratory mission is to increase lab reliability through automation of processes and reduction in manual transcription of data, improved electronic control and data capture, delivering Data Integrity and Efficiency value using global lab systems and interfaces.

With the iLABs project master data activities in the eLIMS system are needed, existing eLIMS master data needs to be updated and new master data needs to be created by the MD (Master Data) Leads. The position will partner with the MD Leads to understand plan, process, status and escalations and create 1 regular overview with updates, accomplishments and risks.

Who are you?

  • Bachelor’s Degree Office Assistant or Secretary/Languages Education with 5-10 years relevant experience
  • Experience in a complex working environment
  • Experience in a Compliance or Quality environment and understand the need to work accurately in line with existing Standards and Processes
  • Enjoy working in a team, transparent and open to discussion
  • Customer oriented and resistant to stress
  • Self-starter with a hands-on mentality
  • Strong written and verbal communication skills in English and Dutch
  • Proficiency in MS Office (Microsoft Word, Excel, Outlook and PowerPoint) and Adobe Acrobat
  • Excellent planning, scheduling and organizational skills with sense of priorities
  • Performs other tasks as assigned.

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Are you interested? Apply now with your cv!

 

Quality Assurance Officer

  • Location: BEERSE
  • Type: Contracting
  • Job #17417

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Quality Assurance Officer

This role is situated within the eLIMS Center of Excellence, and independently creates, updates and maintains high quality Master Data within eLIMS, integrates instruments and applications within eLIMS, performs user acceptance testing and translates specifications within the eLIMS system by utilizing current business processes.

You are someone who takes ownership by completing any incoming requests in a timely manner. You escalate any issues and understand the impact towards other customers when changing/updating existing Master Data. To maintain high quality data, you collaborate with customers to fully understand the Master Data requirements and will review all configurations for accuracy and completeness.

In this role you mentor, lead, and train team members.

You collaborate with multiple internal customers (e.g. Large molecule, Small Molecule, Research and Development…) to fully understand the Master Data requirements and will review all configurations for accuracy and completeness.

In this role you are able to lead small projects within the Center of Excellence, e.g. Harmonization/standardization of processes.

Scope of work:

  • 75 – 85 % – creating, updating, reviewing & approving Master Data including worksheet templates, worklist templates and sample plans, specifications
  • 10 – 20% – Maintaining system related documentation (procedures, events, etc) with the appropriate applications (Docspace, Trackwise, Clearquest, Q-Test or any other designed system; Participating in system related project activities as requested by the CoE lead including review and testing of system updates
  • Coordinating eLIMS activities with the local labs; Updates eLIMS instrument master data, eLIMS Empower master data, eLIMS LES master data and uploads Smart QC Master Data
  • Creating test scripts for user acceptance testing, and executes user acceptance testing using customized test scripts from the local labs
  • Participating in capability development activities according to training requirements
  • Provide feedback to CoE team lead regarding eLIMS activities performance
  • 5 % – Provide feedback to CoE team lead regarding eLIMS activities performance

Who are you?

  • A Bachelor's degree or equivalent education is required. You have 3 – 5 years of experience. Knowledge & experience with LIMS is required
  • You can manage multiple issues, organize activities, prioritize, and escalate to management when appropriate. They must be precise and accurate on the data they are managing
  • You have broad knowledge and experience with cGMPs, regulations, risk management. Previous Quality Systems experience is required
    • Knowledge of/familiarity with other appropriate lab systems (Empower/SDMS/LES) is a plus
  • You have decent written and verbal communication skills (At least English – B2).
  • You have experience working in a pharmaceutical or another highly regulated industry. Experience with quality assurance, quality control, analytical testing or IT is a plus
  • You are flexible to adapt to urgent needs
  • You have the ability to interact with Local lab leaders where necessary regarding master data related issues. They must have the ability to maintains strong relationship with Local Labs and maintain a clear line of communication with the eLIMS CoE lead. They must have a strong customer focus and be dedicated to meeting customer expectations as determined by the CoE lead. 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

 

Are you interested? Apply now with your cv!

 

EMEA Regulatory Compliance Manager

  • Location: BEERSE
  • Type: Contracting
  • Job #16944

 Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

 

EMEA Regulatory Compliance Manager

Department: Global Regulatory Affairs

Reports to: EMEA Regulatory Liaison or EMEA Regional Therapeutic Area Leader

Summary of current position to be filled: A regulatory affairs professional who can support the regional regulatory strategy for products in the oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations.

Job Description

1. Input in development, post-approval and Life cycle management

• Participate in global regulatory team meetings as appropriate
• Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
• Have an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic area

2. Liaison with Regulatory Agencies and Local Operating Companies

• Act as back-up for contact with Regulatory Agencies as needed
• Draft cover letters for Regulatory Agency communication
• Assist in the preparation of meetings with Regulatory Agencies
• Liaise with LOCs, track and respond to queries in a timely manner

3. Input in document and process development

• Assist in development of processes related to regulatory submissions
• Draft and review some document content (depending on level of regulatory knowledge / expertise)
• Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
• Track dates of submissions and Regulatory Agency responses

4. Clinical Trial Applications (CTA)

• Review protocols and ensure alignment with regulatory requirements
• Advise team on required documents and submission strategies in preparation of CTAs
• Ensure CTA submission packages are complete and available according to agreed timelines
• Review and approve clinical trial supply plans

5. Marketing Authorization Applications (MAA)

• Provide regulatory support throughout registration process
• Provide regulatory support throughout life-cycle management
• Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
• Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
• Assist with submission and acceptance of MAA
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans

1. Job Requirements

Education and experience
• University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
• Experience in regulatory affairs
• Teamwork experience

Skills
• Project management skills
• Oral & written communication skills
• Organization & multi-tasking skills

Knowledge
• Knowledge of the regulatory environment, guidelines and practice of EMEA regions

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Are you interested? Apply now with your cv!

EMEA Medical Operations Specialist

  • Location: Beerse
  • Type: Contracting
  • Job #16922

EMEA Medical Operations Specialist (EMOS)

Zaventem – Contracting

#MAF #HCC #EMEA #Medical #budgetmanagement

Our partner is looking for a EMEA Medical Operations Specialist to join its team.

What are your responsibilities?                               

As an EMEA Medical Operations Specialist, you will be responsible for overall budget management taks, organize and attent medical event with the EMEA MAF and MedEd team(s), and ensure that all activities are carried out in compliance with regulatory guidelines, HCBI and company policy.

  • Budget management tasks
  • Responsible for overall budget tracking by consolidating information acquired from agencies, internal stakeholders and Janssen finance
  • Support consolidation of budget in accordance with finance update cycles, escalating budget discrepancies as appropriate
  • Follow-up with involved agencies on budget estimates and work orders/contract
  • Request PO numbers and work closely with the EMEA Event Support Team
  • Follow up on invoices and reconciliations
  • Responsible for budget planning, tracking and reporting of events, sponsorships, grants and consultancy agreements
  • Medical Event Planning
  • Coordinate the planning of Medical HCC sensitive meetings with less than 30 external participants working closely with the EMEA MAF and MedEd team(s)
  • Organize and attend planning meeting(s) with the respective EMEA team(s) and stakeholders and contribute to review of annual plans for Medical activities, Educational Grants and Consultancy agreements
  • Proactively reach out to Event/Grant/Consultancy agreement owner (or escalate) in case of discrepancy between Annual planning and currently requested activities
  • Event Project Management
  • Responsible for preparation, set up, conduct and closure of Medical meetings with less than 30 external participants
  • Together with internal event owner, select & contract medical communication and logistics agency for each meeting, ensure compliance with established rate card as determined by procurement
  • Act as primary contact point for external participants and medical communication agencies
  • Arrange all the logistic for the meeting and the external participants
  • Closely work with the EMEA Event Support team to follow contract and payment processes.
  • Close and reconcile events against agreed budgets
  • Educational Grant/Consultancy or speaker agreements management
  • Together with the team, obtain the required documentation for submission
  • Advise the requester on local HCC requirements or specificities
  • Closely work with the EMEA Event Support team to follow contract and payment processes
  •  Management all healthcare compliance aspects related to meeting project management (?30 HCPs) and Educational Grant/Consultancy or speaker agreements management:
  • post meeting reconciliation, filing and archiving,
  • Coordinate transfer of value (ToV) and disclosure
  • Ensure that all activities are carried out in compliance with regulatory guidelines, HCBI and company policy
  •  Maintain open communication and cooperation with other individuals in EMEA Medical Affairs Team to ensure knowledge exchange and sharing of good practice.
  • Look for efficiencies and improvements in the related business processes

Who are you?

You have an experience in budget or finance and a background in medical, healthcare or pharmaceutical meeting. You also have project management skills and have experience in working in a complex and virtual environment. Excellent interpersonal, organizational skills, time-management skills and communications skills, both written and verbal. Proven skills at developing and managing varied relationships within and outside the company. Awareness of Healthcare Compliance. You can identify and resolve issues that arise during execution of task. You are fluent in English and additional EMEA languages is an advantage. You are flexible to travel occasionally within Europe.

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.

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Yannick Kizito: [email protected].