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Project Manager in vitro Drug Metabolism and Pharmacokinetics

Charles River Laboratories International Inc (CRL)

Den Bosch (S-Hertogenbosch), NL, 5231 DD

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Functie

Are you up for a new challenge? For our in-vitro Metabolism Team in Den Bosch we have a challenging opportunity for a Project manager with a wide variety of tasks and responsibilities in a combination of regulatory aspects and science. 

At Charles River Laboratories Den Bosch we are currently hiring a: 

Project Manager in-vitro Drug Metabolism and Pharmacokinetics 

Department: 

The Discovery & Environmental Sciences department consists of approximately 90 employees. Within this department, research is carried out into the safety of existing and new substances. Characteristic of the work is the great diversity of tests, test substances, customers and collaborations. 

Section Drug Metabolism & Pharmacokinetics:   

Within the Drug Metabolism & Pharmacokinetics department research is performed into the absorption, distribution and metabolism of different compounds. These can be pharmaceuticals, agrochemicals, chemicals and food ingredients. The studies are performed in in-vitro models like hepatocytes, but also in blood or plasma. In the department, we also perform the analytical analysis with LC-MS to quantify compounds in the in-vitro models. In order to investigate metabolites formed in these in-vitro models, we work with state-of-the-art high resolution MS instruments. 

Team:

The team consist of 9 scientific project managers supported by a team of 14 technicians. Within the team there is an open and flexible culture and a pleasant and informal atmosphere, where everyone supports each other and where you are valued. 

About your role: 

You will be managing regulatory experiments ("studies") as a Project Manager (GLP title = Study Director). You are responsible for the implementation, execution, and interpretation of in-vitro studies in the field of absorption, distribution and metabolism. As a Project Manager, you take care of and have the responsibility for the progress and the quality of the studies, the scientific content and the interpretation/reporting of the study results. Both the biological part of the studies as well as the analytical part will be under your supervision. You are also responsible for developing, implementing and validating the required analytical methods. You will be working in a recently renovated laboratory (2021) equipped with state-of-the-art analytical equipment. 

These studies are performed for pharmaceutical companies, agrochemical industry, chemical and food industry companies. You could be running a study for a newly developed pharmaceutical treatment one week, and for a novel food the next.  

We want you to do what you are good at, while enjoying the support and company of an enthusiastic team of scientific project managers and motivated technicians that will help you to fulfil your potential and fine-tune your skills and expertise where needed. 

Short Description

Primary responsibilities:  

  • Responsibility for your studies from start to finish, which includes planning, study design, preparing protocols, evaluation of (interim) results, communication of potential issues and final results to our clients, discussing interesting findings with your team members, and preparing a comprehensive report for the client; 
  • Monitoring validity and scientific quality of your studies; performing quality checks of ongoing studies; 
  • Advising clients on most appropriate study designs and testing strategies, and building a trust-based relationship with returning clients; you will receive training from experienced experts in the relevant fields in order to develop the required skills; 
  • Working closely together with direct team members, experienced technicians, analytical experts, administrative support groups, client services team, and regulatory expert; 
  • Depending on your personal interests and existing competencies, you could participate in a specific innovation team or one of several subject matter expert groups.

What is required:

  • You are a graduate with a PhD degree in (bio-)analytical chemistry, or comparable education. PhDs with a degree in a biomedical science can also apply.  
  • You have experience with working in a laboratory setting with H/UPLC and/or (high resolution) LC-MS.  
  • You have also worked with cell systems like hepatocytes, microsomes and/or recombinant enzymes or cell cultures. 
  • Experience with large molecule LC-MS analysis (ADC, antibodies, oligonucleotides) is an advantage. 
  • You enjoy and excel in troubleshooting. 
  • You have excellent communication and reporting skills, both in Dutch and English.  
  • You have a pro-active, results-oriented, enthusiastic, dynamic and flexible attitude. 
  • You enjoy working in a team but also on your own, and you can work with high quality and efficiency. 
  • Understanding of Good Laboratory Principles (GLP) and certification to work with radioactive materials is a plus. 

Our offer: 

Working at our organization means working in a dynamic international organization with a modern laboratory and a wide variety of equipment and techniques at your disposal.  

In addition, we offer excellent primary and secondary working conditions including:  

  • Ongoing training and support;  
  • 27.5 holidays and 2 collective days per year;  
  • Possibility to purchase 10 additional holidays per year;  
  • Annual one-off 8% holiday pay of your gross annual salary;  
  • Annual one-off payment based on company results;  
  • Travel allowance at €0.2 cents per kilometer with a maximum of €250 net per month or an NS Business Card;  
  • Bicycle (lease) plan;  
  • Collective pension with a small own contribution of 2.9%;  
  • Company fitness membership;  
  • The opportunity to play sports with colleagues on our own sports field;  
  • The possibility of a consultation with our in-house ergonomist;  
  • Free fresh fruit every day.  

  Do you have any questions about this vacancy? For further information about the position, please contact Janneke Basten +31638857962. If you are interested in this position, we invite you to apply via our career site: Careers | Charles River (criver.com)  

Acquisition in response to this vacancy is not appreciated.

About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

Job posted: 2024-04-02

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