CMVS Coordinator

Company Description

Business Unit Eurofins PROXY is part of the international operating Eurofins Scientific and is a GMP Quality Control laboratory, where analytical chemical testing of raw materials, drug substances and drug products is performed. A large part of this work comprises routine compendial testing. However, for new products, formulations or monographs clients require development or validation of analytical methods.

Job Description

The CMVS Coordinator is responsible for initiating and overseeing the operational process of Compendial Method Verification Studies (CMVS) within the Business Unit Raw Material Testing of Eurofins Proxy. This role involves close collaboration with various stakeholders in the end-to-end CMVS process, including the Small Molecule Drug department of the Business Unit Studies & Finished Products, Business Development, Analytical Review, and QA. As part of the QC Raw Material Testing department, you report to the Manager QC. Your responsibilities include:

• Overall management of incoming CMVS requests, involving coordination, assessment, planning, and client communication.
• Assisting in the preparation of quotations for CMVS.
• Executing assessments on CMVS requests following the initial assessment by the Business Support team.
• Translating the outcome of CMVS assessments into CMVS protocols and/or work plans.
• Writing CMVS reports after the execution of the studies in the QC laboratory.
• Updating the CMVS archive and history.
• Transferring finalized and successful CMVS projects into routine QC operations.
• Further developing and optimizing CMVS capabilities within the Business Unit Raw Material Testing.
• Reviewing and interpreting generated data when necessary.
• Troubleshooting company-wide laboratory matters.
• Conducting investigations into complaints and deviations and reporting them to QA.
• Managing corrective and preventive measures in the event of complaints and deviations.

Qualifications

• You have a scientific background (at least BSc or scientific working experience) in analytical chemistry, biochemistry, or organic chemistry.
• You possess an entrepreneurial mindset, exploring possibilities and opportunities.
• You have experience in the development and validation of analytical methods, preferably in chemistry or CMVS.
• You are independent, enthusiastic, goal-oriented, efficient, and accurate, thriving in a fast-paced environment.
• Capable of running several experiments in parallel and working flexibly.
• You enjoy working in a team, welcoming and using feedback as an opportunity to learn and grow.
• Fluent in English (basic knowledge of Dutch is an advantage, but not a requirement).

Additional Information

PROXY and Eurofins: Plenty of Opportunities

This position is located at Eurofins PROXY on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration take center stage. We offer a responsible and challenging role within the team with room for your own ideas and contributions. Eurofins PROXY further provides:

• Competitive salary
• Flexible working hours
• 25 vacation days (with the option to purchase an additional 7 vacation days)
• Travel expense reimbursement. If you use public transportation, your travel expenses will be fully reimbursed
• Participation in a pension scheme with a 50% contribution from Eurofins
• 8% individual choice budget, usable for extra salary, vacation days, additional pension contributions, and more
• Discount on supplementary health insurance
• A bike and/or fitness arrangement to promote vitality
• Professional training opportunities and possibilities for education and development
• Training possibilities through the online learning platform Good Habitz

When you work at Eurofins PROXY, you experience the benefits of Eurofins as the parent company. Our ambitious growth plans offer opportunities for the organization and our employees:

• Abundant growth opportunities
• A large client portfolio ensures a diverse range of tasks in your work.

Acquisition for this vacancy is not appreciated.

Eurofins Scientific is an international listed life sciences company that provides its customers with high-quality laboratory research and advice.

With EUR 6.7 billion in annual revenues and over 61,000 employees in ca. 900 laboratories across 61 countries, Eurofins Scientific is a leading international group of laboratories providing a unique range of analytical testing services to the pharmaceutical, food, environmental and consumer products industries and to governments. In addition, Eurofins is one of the world's largest providers of testing and laboratory services in genomics, forensics, CDMO, advanced materials science, drug development and clinical studies. Eurofins uses a unique amount of analysis methods and an unprecedented high level of knowledge and expertise.

Our people at Eurofins make an important contribution to issues such as the environment, food and general health. Employees are proud of the work they do and experience a lot of freedom in the performance of the job. Responsibilities are as low as possible in the organization so that the people with the right information can start taking the right ones. Eurofins invests structurally in the personal development of talent, both in the field of leadership, growth potential and substantive knowledge.