#Hiring: Senior technician analytical (bio)chemistry

Senior technician analytical (bio)chemistry

- a senior expert with organizational skills -

Currently, we have a vacancy for a senior technician analytical (bio)chemistry to pursue our ambitious endeavors in in-house product development projects and in various collaboration projects with renowned third parties.

The position

In your position as senior technician analytical (bio)chemistry, you will be responsible for all analytical aspects across various projects, to meet the deliverables within agreed timelines and budget. You will identify the key analytical questions and provide theoretical and experimental support to address these. As member of the CMC team you will also work in cross-disciplinary teams (including CMC, preclinical and clinical colleagues) as well as with co-development partners, including academic and industrial parties. As senior technician you are the point of contact for all activities in the lab and therefore responsible for a smooth organization and execution of lab activities.

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The challenge

In your job as senior technician (bio)analytical chemistry you are responsible for all analytical activities, either in-house or at third parties:

·??????Analytical activities means analytical method development, qualification and validation but also stability assessments based on the applicable guidelines

·??????Analytics can be either from CMC perspective as well as characterization in biological samples

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More explicitly

·????Lead the analytical development of our nanobiologic programs

·????Guiding the leanest & meanest approach for analytics

·????Supervise all stability related projects, in-house and externally

·????Responsible for all analytical related QA documentation

·????Responsible for all analytical (sub)chapters in regulatory documentation

·????Excellent communication to management and project teams, incl. risk mitigation where appropriate

·????Provide analytical support where required and/or pro-actively is considered essential

·????Oversight of the analytical lab, in close alignment with the R&D production facility

·????Supervise the analytical team?(including interns if applicable)

·????Establish GMP analytical lab,?if applicable

·????Take part in project teams, and as a member you will:

·????Identify the key analytical questions per project, determine the required quality levels, select the most appropriate analytical approaches

·????Contribute to scientifically sound project plans based on mutually defined quality criteria together with the project team (and external collaborators where applicable)

·????Execute agreed project plan in line with pre-set quality levels on content, timelines and budget (including resources)

·????Create a lab organization in which activities are performed in a high-quality setting according to the company’s quality system including training and coaching of (new) lab colleagues

·????Assure optimal performance of lab equipment incl. via the equipment management system and consumable and material stock control

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The profile

·????Bachelor in analytical or bioanalytical chemistry

·????Proven track record in (bio)-analytical development projects, ideally experience in the field of innovative (polymeric) drug products and/or nanoparticle formulations

·????At least 5 years of industrial experience with the design and conduct of analytical development projects; preferably within an internationally operating company

·????Experience with sophisticated method development, mainly chromatographic (LC, SEC) and various detection techniques (UV, CAD, RI, MALs, MS) but also other techniques

·????Experience with using and improving a QA/QC system, accordingly familiar with infrastructure and corresponding guidelines

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Your skills

·????Good communication skills and excellent organization skills

·????You have the ability to work on multiple projects under time pressure without compromising on quality

·????Analytical and creative problem-solver

·????You are a self-starter who thrives in a flexible environment with a pro-active multi-disciplinary mind-set

·????Quality awareness

·????Team player, eager to contribute to the success of an innovative company

·????Fluent in English both in word and writing

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What TTxD offers

·????Opportunity to use your talents and competences in the development of innovative drug products

·????Further industrial training, including goal-oriented project management

·????Work in a multidisciplinary team with ambitious colleagues

·????A competitive remuneration package

·????Opportunities to grow both from content perspective as well as on a personal level

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Is this your next growth step?

Please send your C.V. and motivation letter in English to the attention of Dr. Cristianne Rijcken (CMC Lead) to email-address: [email protected] before 15 July 2023.

For further information about the position, please contact her at +31 6 24 55 91 75

About Trained Therapeutix Discovery (TTxD)

Trained Therapeutix Discovery (TTxD) is a biotech company based on the Pivot Park, Oss, The Netherlands. TTxD has established scaled and GMP-ready manufacturing for two lead products, one designed to induce trained immunity for cancer immunotherapy and the other for treatment of inflammatory diseases.

Nanobiologics are biocompatible nanocarriers developed by Prof. Dr. Willem Mulder at the Icahn School of Medicine at Mount Sinai. They consist of phospholipids, cholesterol, and apolipoprotein-A1 (apoA-1).[1] The latter provides structural integrity to the lipid nanocarrier and is the predominant protein in high-density lipoprotein.[2-4] Using an innovative prodrug strategy1, these myeloid cell-avid nanomaterials can be easily functionalized to create effective nanotherapeutics for targeting the innate immune system. Nanobiologic and prodrug methodology is compatible with a variety of small molecule drugs.[1] To date, we have stably loaded nanobiologics with prodrugs of over 10 different small molecule therapeutics, without notably affecting nanobiologics’ size or in vivo behavior. This platform's efficacy has been demonstrated in mouse models of cancer, atherosclerosis, and transplantation.[5-8] Nanobiologics' clinical translatability has also been confirmed by studies in various large animal models, including rabbits, pigs, and non-human primates.[1,5,6,9] To achieve clinical translation, Trained Therapeutix Discovery obtained an exclusive license from Mount Sinai in 2019.

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Literature reference

1. van Leent, M. M. T. et al. A modular approach toward producing nanotherapeutics targeting the innate immune system. Sci Adv 7, (2021).

2. Linsel-Nitschke, P. & Tall, A. R. HDL as a target in the treatment of atherosclerotic cardiovascular disease. Nat Rev Drug Discov 4, 193–205 (2005).

3. Wasan, K. M., Brocks, D. R., Lee, S. D., Sachs-Barrable, K. & Thornton, S. J. Impact of lipoproteins on the biological activity and disposition of hydrophobic drugs: implications for drug discovery. Nat Rev Drug Discov 7, 84–99 (2008).

4. Kingwell, B. A., Chapman, M. J., Kontush, A. & Miller, N. E. HDL-targeted therapies: progress, failures and future. Nat Rev Drug Discov 13, 445–464 (2014).

5. Priem, B. et al. Trained Immunity-Promoting Nanobiologic Therapy Suppresses Tumor Growth and Potentiates Checkpoint Inhibition. Cell 183, 786-801.e19 (2020).

6. Lameijer, M. et al. Efficacy and safety assessment of a TRAF6-targeted nanoimmunotherapy in atherosclerotic mice and non-human primates. Nat Biomed Eng 2, 279–292 (2018).

7. Tang, J. et al. Inhibiting macrophage proliferation suppresses atherosclerotic plaque inflammation. Sci Adv 1, (2015).

8. Braza, M. S. et al. Inhibiting Inflammation with Myeloid Cell-Specific Nanobiologics Promotes Organ Transplant Acceptance. Immunity 49, 819-828.e6 (2018).

9. Binderup, T. et al. Imaging-assisted nanoimmunotherapy for atherosclerosis in multiple species. Sci Transl Med 11, (2019).