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Our people help shape the future of life sciences

Have a look at our vacancies

Our ambition is to enhance the quality and safety of medicines and help shorten the time to market for drugs and medical devices that improve the quality of life. Working alongside smart and driven colleagues, you can make a lasting impact on our customers, the industry and patient health around the world. Within a consultancy environment, knowledge and experience are important, but we also welcome people who are just embarking on their career. We provide a culture where being result-driven, enthusiasm and being passionate about your job are equally important.

More about Xendo

  • A rapidly developing organisation with ample career opportunities
  • Working on various projects offers the chance to gain substantial experience
  • Xendo invests extensively in training and education
  • Based in 4 countries, our professionals ensure worldwide delivery of services

Meet some of our extraordinary people

Angella Angiji

As a Graduate in Molecular Life Sciences, Angie is fascinated by science in general and its importance and contribution to human health. She has a proven track record in science and strong communication skills, she is also comfortable with new environments, tasks, and working with many different types of individuals; making her an ideal candidate for our Young Talent program. Currently, she is active in our Adverse Event Managment team while increasing her expertise with a Masters in Pharmacovigilance.

Joost Havers

Joost has a background in Mechanical Engineering and has been involved in data management and validation on a personal level as well. Following an internship at Xendo he started as a Quality Engineer in which function he developed several services like asset management and computer systems validation and is now one of our longer-serving employees.

Currently working as managing consultant, he has built up his own team surrounding these services and is successfully executing a wide variety of projects and is also a board member of the local ISPE GAMP-COP.

Liesbeth Hof

With a background in medical biology, Liesbeth worked in big pharma for over 10 years. During these years she was actively involved in the development and execution of global regulatory strategies across therapeutic areas. She truly enjoys working as a consultant as it allows her to bring in her regulatory knowledge and wide range of experiences towards Xendo and towards the clients. It is a pleasure for her to work with the clients, being in direct contact with them and contributing to their product life cycles whether it involves hands on work or strategic advice.

Marc Stegeman

I am Marc Stegeman and I work as a Principal Consultant and Black Belt with Xendo. I very much enjoy my work as a consultant. It brings together all my experience gained as a specialist and manager in QA, regulatory, Lean Six Sigma and manufacturing. Most of this type of work I did in previous jobs, at one company, at one site. Today, this context has been expanded while doing this work at different places, at different customers with different interests and moods, but in one week.

Vacancies

#HR Manager

You are ready for your next step as independent country HR Manager NL in a matrixed environment. This position requires an extremely perceptive person who is capable to relate individuals at all levels within the organisation while remaining sensitive to business needs and employee goodwill. Your challenge will be the development and implementation of the policies & procedures in line with Xendo’s growth ambitions, in an ever changing marketplace. The position is based in our office in Leiden on a full-time work schedule.

XENDO

Xendo is a leading, independent consultancy and project management organisation in the (bio)pharmaceutical, medical devices and healthcare fields. The company’s ambition is to enhance the quality and safety of medicine and help shorten the time to market for drugs and medical devices that improve quality of life. For over 25 years Xendo has supported hundreds of clients in more than 25 countries worldwide.

TEAM

The HR team consists of an HR Officer and a Talent Acquisition Manager. You will report directly into the CEO.

WHO WE ARE LOOKING FOR

A professional with demonstrated ability to function successfully in a fast paced, growing industry. You have a sound knowledge of local labor laws and government requirements and you are detailed-oriented with excellent organisational & documentation skills

THE POSITION

The HR Manager is the primary point of contact for all employees and act as advisor to (senior) management on all HR related matter. The focus of the position will be on Talent Development and management of the Dutch staff in a scale-up environment. The HR Manager navigates managers and employees through talent management processes as well as performance management and succession planning. He/she is responsible for the further development of our organisational effectiveness and continuous improvement of HR processes and procedures. This all in line with the corporate strategy to aim for speedy HR service and flawless HR administration in a growing consultancy environment.

YOUR PROFILE

  • Degree in HR Business Administration (preferably Mad degree in Human Resources or equivalent with focus on HR Management).
  • 5-7 years of experience as a HR generalist, ideally in the life science industry.
  • Experience in a scale-up and / or international environment with focus on organisational development and talent management is a plus.
  • Ability to build strong relationships in an international matrixed organisation.
  • Desire to work hands-on to pro-actively shape an organisation.
  • Passion for working in a fast growing , international environment.
  • Champion organisational change.
  • Business oriented team player with great communication and advisory skills.
  • Fluent in Dutch and English.


INFORMATION


For further information, please reach out to or +31615144124

OUR OFFER


a dynamic and varied position in a fast-growing and professional company;
a challenging and exciting work environment.
good terms of employment.
focus on continuously extending knowledge and experience.

APPLYING


If you are interested in this position, we encourage you to send your motivation and CV to us:

Xendo B.V.
Att.: HR department
P.O. box 255
2300 AG Leiden or email to:

#Consultant Medical Devices

We are looking for people who like to share their extensive knowledge to support our customers in the field of medical devices. You will be part of the medical device team preparing solutions, efficient and target oriented, and taking the lead and responsibility in the execution of our projects. You like to combine communication skills with in-depth medical device knowledge to ensure that any innovative solution is transferred to our customers in the most efficient manner. Working locations vary between Xendo and customer offices.

Company

Xendo is a consultancy and project management organisation in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.

 

Team

Medical Devices, reporting to the managing consultant.

 

Who we are looking for

Those who dare to make the difference – in the way they act, collaborate and lead. As a Consultant you will have the opportunity to share your extended knowledge in the field of Medical Devices with Xendo’s clients and closely collaborate with colleagues across divisions. Addressing new challenges and finding innovative solutions is your prerogative. Mostly working on-site, at the client's premises, you welcome independent responsibility for your projects. 

 

The position

You will work independently or jointly in a team for our customers with activities in the medical device industry. The scope of your consult, advice and project work will encompass (worldwide) product registration, defining regulatory strategies, dossier writing or review, participation and/or arrange meetings with our clients and/or notified bodies and governmental authorities. In addition, services rendered as a consultant can include; interim management, quality assurance, regulatory & clinical affairs or other relevant fields. As a consultant, you will continuously anticipate on future and current relevant developments for our clients. You will be responsible for organising and coordinating projects independently with adequate communication and in full transparency to our clients.

 

Your Profile

  • Bachelor’s or Master’s degree in (para)medical sciences;
  • Relevant knowledge and experience (at least 2 years) in the medical device industry preferably in multiple environments
  • Project Management skills;
  • Customer oriented, passionate and able to effectively switch between different assignments;
  • Ambitious and enthusiastic relation builder with a quality driven mind-set;
  • Excellent proficiency in English and Dutch language

 

Information

Please contact Jan Bart Hak, Managing Consultant at +31 71 524 40 00 or by e-mail for additional information on job specifics.

OUR OFFER

  • A dynamic and varied position in a fast-growing and professional company;
  • Good terms of employment;
  • Consultancy, Project and Interim Management at multiple clients.
  • Our projects span a wide range and in different phases in facility life science; an extended development programme on hard and soft skills.

Applying

If you are interested in this position, we encourage you to send your motivation and CV to us:

Xendo B.V.

Att.: HR department

P.O. box 255

2300 AG Leiden or email to:

GCP

#CONSULTANT GCP

If contributing to improving or establishing the life sciences companies GCP compliance by providing them with the best possible advice and support you should consider joining Xendo as a GCP Consultant.  The job includes working on projects as project manager, high-level consultancy projects (advising clients on the best possible GCP strategy) and auditing for CRO’s, Investigational sites and Sponsor affiliates. You will usually work at the customer’s site, audit location, or from our office in Leiden. Due to the nature of the work approximately 20% of the time you will travel abroad. In short: a chance to apply and further increase your professional knowledge and experience in GxP compliance.

XENDO

Xendo is a consultancy and project management organisation in the (bio) pharmaceutical and medical devices and healthcare fields. Thanks to our multi-disciplinary, knowledge-driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.

TEAM

The Consultant GCP is a member of the Quality Assurance team of the Division Compliance and Validation and reports to the Managing Consultant.

WHO WE ARE LOOKING FOR

A professional with demonstrated ability to function successfully in a fast-paced, changing industry. You are able to bridge between Xendo’s divisions to ensure, deliver and maintain our commitment to our clients in all expert areas within life sciences. You have in-depth knowledge about GCP compliance, good communication skills, persistence and a flexible working attitude.

YOUR PROFILE

  • Bachelor’s or Master’s degree;
  • at least 5 years of experience within a GCP environment;
  • at least 3 years of experience with international GCP quality assurance, including leading and/or co-auditing of different types of audits;
  • good communication skills and interpersonal skills;
  • client-oriented, dedicated, flexible, proven project management skills and able to quickly switch between different assignments;
  • good understanding of Annex 11 and 21 CFR Part 11;
  • understanding of GMP, GLP, GVP, GAMP is a pre
  • excellent in the English language.

OUR OFFER

  • a dynamic and varied position in a fast-growing and professional company
  • good terms of employment;
  • international projects in GCP compliance;
  • projects at both small and large life science organisations and vendors.

APPLYING

If you are interested in this position, we encourage you to send your motivation and CV to us.

Agency or sales calls are not appreciated.

 

#Principal Consultant Pharmacovigilance (Business Development)

Purpose:

The Principal Consultant Business Development strengthens Xendo’s market position, reputation and achieves further growth of the business, both for extending of our existing services as well as for product development. Together with the Division Director Pharmacovigilance the Principal Consultant Business Development Pharmacovigilance defines long-term pharmacovigilance strategic goals, builds key customer relationships, identifies business opportunities, negotiates and closes business deals, maintains extensive knowledge of current and upcoming market conditions and business critical regulatory intelligence.

Positioning:

The Principal Consultant Business Development reports to the Division Director Pharmacovigilance and is part of the PV management team.

Responsibility:

The Principal Consultant works with the Division Director Pharmacovigilance and Pharmacovigilance (Managing and Senior) Consultants, and cross-functional with other Division Directors and Country Managing Directors to increase sales opportunities and thereby maximize reputation and revenue for Xendo. To achieve this, in addition to consolidating and extending our customer base, new potential customers need to be identified and targeted, Xendo’s palette of opportunities proposed to them, to ultimately converted these into packages taken up by these clients, and continue to grow business in the future.
The incumbent will also help manage existing clients and ensure they stay satisfied. The Principal Consultant Business Development will call on clients, often being required to make presentations on solutions and services that meet or predict their clients’ future needs.

Job Description

The primary responsibility of the Principal Consultant Business Development Pharmacovigilance is to entice new clients and bring in new assignments and pharmacovigilance services by networking, calling, social media usage, active participation in congresses and events or other means of generating visibility and interest from potential clients and actively expand current relationships and partnerships. You will operate as the lead point of contact for any and all matters for specific pharmacovigilance accounts and will maintain and build strong, long-lasting customer relationships. You will lead and take ownership for RFP processes from request to contract implementation.

Internal Interaction

The Principal Consultant Business Development Pharmacovigilance works Division Directors, COO, Country Managing Directors, Principal Consultants, Managing Consultants, Senior Consultants and Business Support.

New Business Development activities

  • Prospect for potential new Pharmacovigilance clients exploring opportunities and turn this into increased and profitable business.
  • Identify potential clients, and the decision makers within the client organization.
  • Set up meetings between client decision makers and Xendo senior management.
  • Plan approaches and pitches. Develop proposals that speaks to the client’s needs, concerns, and objectives.
  • Handle objections by clarifying, emphasizing agreements and working through differences to a positive conclusion. Use a variety of styles to persuade or negotiate appropriately.
  • Present an image based on Xendo’s unique selling points that mirrors that of the client.
  • Attend industry functions, such as association events and conferences, and provide feedback and information on market and creative trends.
  • Present to and consult with senior management on business trends or trendsetter ideas with a view to fine-tune existing services and products or developing new services and products based on market demand.
  • Identify opportunities for campaigns and services that will lead to an increase in sales.
  • Call as appropriate within your market or geographic area to ensure a robust pipeline of opportunities. Meet potential clients by growing, maintaining, and leveraging your network.
  • Using knowledge of the market and competitors, identify and develop Xendo’s unique selling propositions and differentiators.

Client Retention

  • Present new (cross divisional) products and services and enhance existing relationships.
  • Work with internal colleagues to meet customer needs.
  • Arrange and participate in internal and external client debriefs.
  • Business Development Planning
  • Management and Research
  • Ensure that data is accurately entered and managed within the Xendo’s CRM system.
  • Forecast sales targets in collaboration with Division Director Pharmacovigilance and ensure these are met.
  • Track and record activity on accounts and leads to close deals to meet these targets.
  • Develop a thorough understanding of the people and capabilities cross divisions.

Education and requirements

  • Bachelor or Master’s Degree with at least 7-10 years of experience
  • Preferably 5 years of sales or business development experience
  • Proven pharmacovigilance expertise and comprehensive understanding of applicable international requirements in this field
  • Prior hands on experience in pharmaceutical industry
  • Experience with alliances, partnering or licensing is considered a plus

Other Skills and Qualifications

Networking, Persuasion, Public Speaking, Research, Writing, Closing Skills, Motivation for Sales, Prospecting Skills, Sales Planning, Identification of Customer Needs and Challenges, Market Knowledge.

#Auditor Pharmacovigilance

As an experienced (Senior) pharmacovigilance auditor you will be responsible for managing and executing the Xendo pharmacovigilance (PV) audit programme you will be conducting audits across the entire range of PV relevant activities, with primary responsibility for planning and participating in global PV audits. The breadth of audits performed include the end to end PV system including PV system key elements, PV QMS , service providers, internal and affiliate audits on behalf of Xendo clients.

Company

Xendo is a consultancy and project management organisation in the (bio) pharmaceutical, medical devices and healthcare fields. Our clients are predominantly operating in the life science sector. Thanks to our multi-disciplinary, knowledge driven approach, Xendo delivers a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations. Our Pharmacovigilance Division that is a legacy of the Vigilex Company became part of Xendo in 2015 The work in this division is performed on a national, EU and Worldwide level.

 

Team:

Audit team within the Pharmacovigilance Division, reporting to the Managing Consultant of the team.

 

Who we are looking for:

Those who dare to make the difference – in the way they act, collaborate, advise and lead. We are looking for a highly motivated and experienced professional who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your clients and the ability to adjust to these needs and function as a partner and advisor to the client is essential. You need to have a pharmacovigilance, medical or paramedical background or a degree in life sciences in combination with a solid knowledge of international pharmacovigilance regulations and guidelines. At least 5-10 years of experience in various roles within pharmacovigilance area or within the pharmaceutical industry with safety related roles, government agency or a PV consultancy organization is an absolute requirement. Audit experience is required and QPPV experience is preferred.

 

The position:

Being a Xendo Auditor you will have the opportunity to work in a wide variety of projects for different companies. This position as (senior) consultant is for the auditors team of the Pharmacovigilance division. Your audit activities will cover the entire range of PV processes, including  from inspection support of our clients, Mock Inspections/ HQ audits, local affiliates/partners/vendors or tailored to a specific PV process. For our various longstanding clients, audit project management and maintenance of a good client relationship will also be an important part of your work. Training clients’ staff on PV regulations or assist in inspection preparations may also be part of your role. Our team is multinational, with several team members working home-based full time.
You may also be assigned as (deputy) QPPV to one or more clients. This concerns mainly smaller and medium-size companies, who often have a PV system under development or are undergoing major changes with (initial) marketing authorization applications. Your input as PV expert is key to these clients, but in addition we also consider (deputy) QPPV work experience a great asset to our auditors’ qualifications as they are through this role involved in all pharmacovigilance relevant processes and procedures of the client.

 

Your profile:

  • Medical or paramedical background or degree in life sciences;
  • Solid knowledge of international pharmacovigilance regulations and guidelines;
  • At least 5-10 years of experience in various roles within pharmacovigilance within the pharmaceutical industry, government agency or a PV consultancy organisation;
  • Audit experience is a must;
  • Good communication and interpersonal skills;
  • Able to quickly adapt to different working environments and the different cultural aspects of our clients;
  • Client-oriented, dedicated, flexible, able to manage timelines and prioritize your work;
  • Excellent knowledge of and experience with pertaining international legislation, guidelines and directives and able to assess the impact of changes in your areas of expertise
  • Proficient in English language, both in speaking and in writing. Good command of a second language is an advantage.

 

Information:

Please contact Helena van den Dungen, Director Pharmacovigilance at +31 71 524 40 00 or by e-mail for additional information on job specifics.

 

OUR OFFER:

  • a dynamic and varied position in a fast-growing and professional company;
  • good terms of employment;
  • focus on continuously extending knowledge and experience;
  • great projects in all aspects of GxP compliance and validation;````````````````````````
  • projects at both small and large life science organisations and suppliers.

 

Applying:

If you are interested in this position, we encourage you to send your motivation and CV to us.

Agency or sales calls are not appreciated

csv consultant

#Senior Consultant (Computer) Validation

As a Senior Consultant of the Engineering & Technical Support Division you will often have a detailed project contract with the client, specifying your activities and the expected results. You will predominantly work on location, but also from home or from Xendo’s Leiden office. Project’s duration can vary from one week (for high level advice/gap analyses) to several months. In short: you feel comfortable in a position that allows you to apply and further increase your knowledge and expertise in the area of GxP compliance and validation. This, amongst others, is your contribution in aim to provide better products for patients.

 

Company

Xendo is a consultancy and project management organisation in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.

 

Team:

IT & Automation within the Engineering & Technical Support Division, reporting to the managing consultant.

 

Who we are looking for:

Those who dare to make the difference – in the way they act, collaborate and lead. As Senior Consultant you will have the opportunity to share your extended knowledge in the field of IT & Automation with Xendo’s clients and closely collaborate with colleagues across divisions. Addressing new challenges and finding innovative solutions is your prerogative. Mostly working on-site, at the client's premises, you welcome independent responsibility for your projects. 

The position:

As a Senior Consultant you will be assigned to (IT) compliance projects within the pharmaceutical, medical devices and life sciences industries. You will mainly work in laboratory, production and validation departments, so knowledge of and experience in these departments is an advantage. Knowledge of GxP and validation combined with a feeling for IT and compliance is a requirement. Your job is to contribute to improving or establishing the clients’ (IT) compliance by providing them with the best possible assistance with their issues. As a Senior Consultant you work on validation projects as project manager, high level consultancy projects in which you advice the client on the validation strategy for implementing IT solutions or interim management functions. In these roles you need besides in-depth knowledge about GxP compliance, good communication skills, persistence and an agile working attitude.

 

Your profile:

  • Bachelor’s or Master’s degree;
  • at least 5 years of experience with GxP compliance and validation in the life sciences sector;
  • experience with validation of computerized systems
  • good communication skills and interpersonal skills;
  • client-oriented, dedicated, flexible, proven project management skills with helicopter view and able to quickly switch between different assignments
  • good understanding of GAMP, Annex 11 and 21 CFR Part 11;
  • excellent in both Dutch and English language.

 

Information:

Please contact Joost Havers, Managing Consultant at +31 71 524 40 00 or by e-mail for additional information on job specifics.

 

OUR OFFER:

  • a dynamic and varied position in a fast-growing and professional company;
  • good terms of employment;
  • focus on continuously extending knowledge and experience;
  • great projects in all aspects of GxP compliance and validation;
  • projects at both small and large life science organisations and suppliers.

Applying:

If you are interested in this position, we encourage you to send your motivation and CV to us

#CONSULTANT CMC REGULATORY AFFAIRS

As a result of the continuous growth of our company including our Regulatory Affairs Division we are looking for experienced professionals in Regulatory Affairs CMC. We offer a challenging environment working within our teams and for a wide range of clients in a role as (senior) consultant RA-CMC.

Being a consultant you will work on a wide range of projects that may cover the complete life cycle of a product from (early) development up to post approval maintenance. The projects range from small molecules to biologicals depending on your knowledge and experience. You can be assigned to customers looking for hands-on support and/or requiring advice on regulatory-CMC. The work may cover all aspects of RA-CMC ranging from development and advise on RA-CMC strategies, implementation of RA-CMC requirements in product development, support in scientific advice procedures, communication with health authorities and RA-CMC (Module 3, IMPD) technical writing. You may work at different sites which may be the office of our client, Xendo office or home based depending on the project requirements. Communication skills are key as you will communicate with many different functions within our client organisations like: RA, QA and QC functions, development, manufacturing but also with health authorities.

YOUR PROFILE

We are looking for highly motivated professionals who like to act in a dynamic environment and are able to adjust to different working environments. You are a self-starter and quick learner with excellent communication skills. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. Experience in CMC Regulatory Affairs within the (bio)pharmaceutical industry or health agencies is preferred. For the role of senior consultant several years in a (senior) CMC related position are required. Depending on your experience it is not an absolute requirement that the candidate will be based in the Netherlands. Fluency in English is required.
You aim for a consistent high quality in your work and deliver on your commitments. You are able to manage timelines and prioritize your work. You are also well aware of the regulatory legislation, guidelines and directives and are able to assess the impact of regulatory changes on the products or portfolio of your customers.

OUR OFFER

We offer a responsible, independent position in a growing and ambitious organization, with the opportunity to develop yourself. We offer a competitive salary and secondary benefits. Xendo has a professional but informal working environment, an extended development program on hard and soft skills, a flexible and pleasant work atmosphere and over 200 international colleagues.

APPLYING

If you are interested in this position, we encourage you to send your motivation and CV to us with the form below.

Agency or sales calls are not appreciated

#SENIOR PROJECT MANAGER PHARMACEUTICAL FACILITIES

The Engineering & Facility Support Division is strengthening its engineering team with a Senior Project Manager Pharmaceutical Facilities. Are you an experienced engineering professional with a proven track record in project management and looking for challenge and growth, then this might be your chance! Xendo is a consultancy and project management organization in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector.

As a Senior Project Manager Pharmaceutical Facilities, you will be responsible for the executing of engineering tasks within multiple projects with a medium to long lead time (0.5 – 4 years). You will manage engineering projects both individually and within a multi-disciplinary team where you will have great influence and responsibilities. Your assignments will vary from conceptual or basic design of new laboratories or manufacturing facilities to consultancy and advice on maintenance management and improvement of maintenance planning as well as technical audits. You will be responsible for realizing all work, in accordance with the agreed budget, timescale, quality and performance criteria within the required procedures (health and safety, GMP, local and corporate standards). At times, you will work at the premises of our clients, but also from the Xendo office in Leiden. With your extended experience in facility engineering and project management, you would be considered a great and valuable asset to our company. You will report directly to the Managing Consultant Facility Engineering.

With your extended experience in facility engineering and project management, you would be considered a great and valuable asset to our company, reporting directly to the Managing Consultant Facility Engineering.

YOUR PROFILE

  • Bachelor’s or Master’s degree in Mechanical Engineering or Installation Technology;
  • Knowledge and experience in the pharmaceutical industry (GMP environment) is a must;
  • Solid Project Management (5-10 years) experience with specific experience within (bio) pharmaceutical (or related industries) and GMP.
  • Project Management skills;
  • Communicative and interpersonal skillset;
  • Customer oriented, passionate and able to effectively switch between different assignments;
  • Ambitious and enthusiastic relation builder with a quality driven mindset;
  • Excellent proficiency in English and Dutch language

OUR OFFER

  • a dynamic and varied position in a fast-growing and professional company;
  • good terms of employment;
  • Engineering, Project and Interim Management at multiple clients;
  • Our projects span a wide range and in different phases in facility life science; an extended development program on hard and soft skills.

APPLYING

If you are interested in this position, we encourage you to send your motivation and CV to us with the form below.
Agency or sales calls are not appreciated

#(SENIOR) PROCESS ENGINEER

Xendo’s Process Engineering team is growing as a result of our focus on biopharmaceutical manufacturing. We are currently searching for a passionate (senior) Process Engineer who will be responsible for translating our client’s manufacturing needs into robust processes and equipment designs, and subsequently turning these into successfully operating facilities. In close cooperation with the client, you develop process descriptions and flow diagrams and turn these into P&ID’s. You generate design specifications for process equipment, follow up on technical procurement details, detailed design, construction, commissioning and qualification. This can be either for a new product in a new facility, or the expansion of an existing facility. It can be for traditional stainless steel equipment or single use systems, and either batch or continuous processing.


We are commonly involved in various challenging projects for the manufacturing of monoclonal antibodies, vaccines and medical devices. You will be dealing with a diverse range of process equipment like bioreactors, filtration systems, chromatography systems and virus inactivation systems.


In the role of Consultant, you advise on processes in development or processes to be transferred to clinical or commercial scale, while as a (Senior) Process Engineer you will be coaching juniors in the team on process technical related situations.
You excel in a dynamic work environment and you work either at the client’s location(s) or at our office in Leiden; this can vary throughout the week.

YOUR PROFILE

  • Bachelor’s or Master’s degree in Life Science Technology;
  • You have 5 to 10-year experience in the design of (Bio)process systems or clean utilities like WFI- and steam systems. A combination of the two is a pré;
  • Experience as a (lead) process engineer at an engineering or pharmaceutical company. Experience in a GMP environment is an absolute must;
  • Communicative and interpersonal skillset;
  • You feel at home in a quality and result-oriented team. You are able to motivate others and convey your knowledge and experience to colleagues and clients;
  • Excellent proficiency in English

OUR OFFER

  • a dynamic and varied position in a fast-growing and professional company;
  • good terms of employment; bonus-arrangement included;
  • gaining quick and diverse experience in engineering, project and interim management at multiple clients;
  • our projects are very diverse and span the entire product life-cycle;
  • an extensive development program on hard and soft skills.

APPLYING


If you are interested in this position, we encourage you to send your motivation and CV to us with the form below.
Agency or sales calls are not appreciated

#SR FACILITY ENGINEER PHARMA

The Engineering & Facility Support Division is expanding its engineering team with a Consultant Facility Engineering. Are you an experienced engineering professional looking for challenge and growth, then this might be your chance!

Xendo is a consultancy and project management organization in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector. As a Consultant Facility engineering, you will be responsible for the executing of engineering tasks within one or more projects with a medium lead time (0.5 – 1 year). You will manage engineering projects individually and within a multi-disciplinary team where you will have great influence and responsibilities. Your assignments will vary from conceptual or basic design of new laboratories or manufacturing facilities to consultancy and advice on maintenance management and improvement of maintenance planning as well as technical audits. All work undertaken needs to be in accordance with the agreed budget, timescale, quality and performance criteria within the required procedures (health and safety, GMP, local and corporate standards). At times you will work at the premises of our clients, but also from the Xendo office in Leiden. With your extended experience in facility engineering and preferably project management you would be considered a great and valuable asset to our company. The Consultant will report directly to the Managing Consultant Facility Engineering.

YOUR PROFILE


• Bachelor’s or Master’s degree in Mechanical Engineering or Installation Technology;
• Solid engineering (5-7 years) experience with specific experience within (bio) pharmaceutical (or related industries) and GMP is desirable.
• Project Management skills; experience in planning, designing and programming projects and preparing estimates using up-to-date IT tools
• Communicative and interpersonal skillset;
• Customer oriented, passionate and able to effectively switch between different assignments;
• Ambitious and enthusiastic relation builder with a quality driven mindset;
• Excellent proficiency in English and Dutch language

OUR OFFER


• a dynamic and varied position in a fast-growing and professional company;
• good terms of employment;
• Engineering, Project and Interim Management at multiple clients;
• Our projects span a wide range and in different phases in facility life science;
• an extended development program on hard and soft skills.

APPLYING


If you are interested in this position, we encourage you to send your motivation and CV to us with the form below.


Agency or sales calls are not appreciated

medical science safety

#Managing Consultant Medical Safety Science

Are you in for an independent and responsible position in a growing organization with the opportunity to develop yourself? Then this might be your chance! Xendo is looking for an experienced pharmacovigilance professional with managerial experience that wants to further build the Medical Safety Science team combined with the option to carry out own assignments for clients as well.

THE JOB

The Medical Safety Science Team consists of a team of experts with very broad experience in analyzing and evaluating data and writing of required periodic reports. Activities in this team have a main focus on report writing (DSURs, PSURs/PBRERs, (development) RMPs), risk and signal management, global literature assessment and providing consultancy or training for clients in the aforementioned areas, both in pre-approval and post-approval phase.

The Managing Consultant leads the team of consultants of the Medical Safety Science team and coordinates the planning of projects and reviews workload for all direct reports. Your line management responsibilities include performance appraisals, time sheet approval, training, professional development, hiring and coaching. You will contribute to the growth of Xendo by building relationships with new and existing clients, identifying opportunities with clients and develop, together with your team of Consultants, new services the future. You provide oversight and guidance on organizational goals and company objectives. In addition to line management responsibilities, you also carry out your own assignments within the scope of the Medical Safety Science team.

This role is a challenging position for someone with extensive experience in leadership and pharmacovigilance. The Managing Consultant reports directly to the Director Pharmacovigilance.

The pharmacovigilance division became part of Xendo in 2013. The work in this division is performed on an EU and worldwide level. You are located in our office in Leiden where the majority of the Medical Safety Science team is based, with the option to work from home as well.

YOUR PROFILE

  • You hold an academic degree in life science, medical or paramedical field
  • Extensive knowledge in report writing
  • Demonstrated leadership and managerial skills
  • Excellent communication skills (oral and written) in English; knowledge of Dutch is a pro
  • You have worked in a wide variety of projects for several companies
  • Analytical skills, proactive, decisive, listening skills, flexible and negotiation skills

OUR OFFER

We offer a dynamic, independent and varied position in a fast-growing and professional company. Xendo has a comprehensive development program on technical and soft skills (e.g. by internal and/or external training, congress participation etc.) We offer a competitive salary and secondary benefits and have a professional but informal working environment.

APPLYING

If you are interested in this position, we encourage you to send your motivation and CV to us with the form below or by email to .

Agency or sales calls are not appreciated

analytics gmp

#Consultant analytics/GMP

Within our Division Compliance & Validation we are recruiting for a Consultant Analytics /GMP who is ready to enter the world of consultancy. As a Consultant you will work in an ever-changing and challenging environment at our clients in the life sciences industries (e.g. (bio) pharmaceutical industry, medical devices, CMOs). You will act as the expert providing support in diverse development as well as GMP projects, e.g. analytical method development and/or validation, lab process improvements and tech transfer. You will also co-develop new R&D and GMP services for Xendo clients within the life science industry. Based on your affinity and experience with GMP (USA and EU) and your expertise in quality management you contribute to the quality (laboratory) management of our clients.

Usually, the work takes place at the clients’ site and entails working in a team of specialists in which related topics such as active substance, drug product, quality and regulatory aspects are discussed.

Currently our Analytics team is involved in the development of a broader range of services to support our customers in improving their processes. As a new team member you are challenged and invited to bring forward your expert ideas to contribute to these new or improved services.


YOUR PROFILE:


For this role, we are looking for candidates with solid experience (4-6 years) in development (R&D), analytical methods for bioprocessing and/or QC testing of biologicals in the life science industry.
You have a bachelor or a master degree in Life Sciences (e.g. biology, (bio) chemistry, biotechnology, biomedical sciences or pharmacy). It is expected that you are able and willing to dig into the details yet keeping an eye on the overall goal of the project. You are result- and client oriented and have adequate interpersonal skills. You feel comfortable working with deadlines in an often changing environment and see it as a challenge to solve issues in a pragmatic and proactive way.
To be successful as a Consultant Analytics/GMP you also have:


• Hands-on knowledge of bio-analytical methods and preferably microbiological test methods;
• Excellent knowledge of requirements for method validation/transfer within a GMP environment;
• Good understanding in GMP, Annex 15 and regulatory requirements related to analytical method development;
• Knowledge of sterile/aseptic manufacturing and/or environmental monitoring is a pre;
• Excellent in both Dutch and English language;


OUR OFFER:


• a dynamic and varied position in a fast-growing and professional company;
• good terms of employment;
• international projects in (bio-)analytical laboratories t both small and large pharmaceutical companies;
• a comprehensive development program on hard and soft skills.


APPLYING:


If you are interested in this position, we encourage you to send your motivation and CV to us with the form below or by email to .
The closing date for applications is June 1st , 2017

regulatory affairs

#(Senior) Consultant Regulatory Affairs

The position

As a result of the continuous growth of our company and the Regulatory Affairs Division we are looking for an experienced professional who like to expand his/her experience in Regulatory Affairs by working in a challenging role as (senior) consultant RA with a coaching function to junior colleagues in a project management setting.


The company

For 25 years Xendo is a leading consultancy organization for the (bio) pharmaceutical industry, medical devices and Life Sciences industry, based at the Bio Science Park in Leiden. In recent years Xendo successfully delivered projects for more than 300 clients. Xendo has an excellent international reputation as a consultancy organization. Most of the work is performed in the Netherlands and Germany, but on an EU and Worldwide level. Our expertise lies in Regulatory Affairs, Pharmacovigilance, OPEX/Quality Management, Engineering, Qualification & Validation, Product Development and E-Compliance & Data Management.

The environment

Being a consultant you will have the opportunity to work in a wide variety of projects and companies. Assignments may cover all aspects of regulatory affairs ranging from pre-approval and scientific advice meetings to regulatory maintenance, from CMC to regulatory project management and from work on small molecules to high-tech (biological) products.

Depending on your expertise, experience and interest you will be assigned to customers looking for hands-on support and/or requiring advice on regulatory strategic issues. The duration and size of the projects can vary from months to years, from 5 days a week to a couple of hours a month and from working at your own home to the office of the customer. Besides you will be the coach for associate regulatory affairs consultants and keep track of their work within in the different projects.

Your profile

You are an entrepreneur, able to think and act at a scientific level, who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. At least 5-7 years of experience in regulatory affairs within the pharmaceutical industry or government agency is a requirement.

With these experience you are curious about new opportunities for yourself, the client and Xendo, a self-starter and quick learner with excellent communication skills. Your Dutch and English are fluent.

You aim for a consistent high quality in your work and deliver on your commitments. You are able to manage timelines and prioritize your work. You are also well aware of the regulatory legislation, guidelines and directives and are able to assess the impact of changes in this area on the products or portfolio of your customers.