Job description

As part of the expansion of our R&D team, we are looking for an enthusiastic and motivated Senior Scientist who likes to play a leading role in the scientific development of our products.  Are you the senior scientist who has industrial experience in late-stage development, has a hands-on mentality, and is a team player? Then we are looking for you! Do you want to join our team? Then read further…..

The organization

Nanomi is leader in the field of microsphere and nanoparticle development of long-acting release injectables. The company is located in the green surroundings of Oldenzaal and is a subsidiary of Lupin ltd. The Nanomi team is young and internationally oriented. The working atmosphere is informal and dynamic, with personal development and humor as important pillars.

There are three different well-equipped laboratories in our state-of-the-art facilities. At the formulation laboratory the small-scale development of microsphere and nanoparticle long-acting release injectables takes place, whereafter the process laboratory scales up to commercial scale. The analytical laboratory takes care of all the analyses related to the development of our products, as well as GMP QC testing. As a team, we strive for high quality and efficient output. You will have a leading role in the scientific development and method validation, maintaining good contact with Project Management, Analytical Chemists and Process and Formulation engineers, to ensure scientifically-sound output. Furthermore, you will write detailed experimental plans, contribute to the execution of the work and data interpretation. You will deliver reports that can be used in (A)NDA/IND filing procedures.  Next to that, you keep up to date with relevant current regulatory guidance and scientific literature and ensure that new knowledge methods are implemented within the organization.

Responsibilities

• Provides technical leadership and subject matter expertise (SME) in cross functional formulation, process and analytical investigations.
• Ensures scientifically-sound and regulatory compliant technical/analytical output by chemists and technicians of the internal Nanomi organization. Supports internal project (sub)-teams at technical level and ensures progress in the project.
• Writes detailed experimental plans defined by the project team.
• Delivers regulatory compliant and scientifically-sound output in the form of experimental work protocols and reports, including data interpretation. The quality should be such that the output can be used in pharmaceutical dossier and/or patents.
• Keeps up to date with relevant scientific literature and regulatory guidance. Follows and studies external developments in the field and implements them into the organization. Visits (inter)national events on the relevant topics.
• Ensures that new knowledge, methodologies and technologies are implemented within the organization.
• Supervises tech-transfer and external subcontracted development activities to ensure sound and regulatory compliant analytical output.

Functional contacts

In the role of senior scientist you have functional contacts with:

• Engineers, chemists, technicians to ensure scientifically-sound experimental output.
• Project management and line management to report on technical progress and experimental planning.
• Suppliers and subcontractors on technical aspects.
• R&D centers, universities and pharmaceutical conferences.

Profile

• Knowledge: comparable to PhD in a relevant field of Pharmaceutics, Chemistry or Chemical Engineering or related scientific disciplines.
• Experience: PhD with at least 5 years or MSc with at least 7 years of industrial experience in the field of (bio-) pharmaceuticals (preferred), medical devices, food or biomaterials.
• Skills: Writing of experimental plans, protocols and reports at PhD level. Independent set-up, execution and reporting of experimental designs. Independent statistical data interpretation.
• Competences: Result-oriented, creative, communicative team player, independent thinker, overview, hands on mentality.

Interested? Please contact us! We are happy to receive your CV and motivation letter