Senior Analytical Scientist-Biologics Evidence Lab (all genders) at CLADE GmbH

Esslingen am Neckar, Baden-Württemberg, Germany -

Full Time

Start Date

Immediate

Expiry Date

13 Sep, 26

Salary

0.0

Posted On

15 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biologics Analytics, Experimental Design, DoE, Spectroscopy, Chemometrics, Analytical Method Development, Data Analysis, GMP/GxP, Scientific Writing, Protein Characterization, HPLC/UPLC, FTIR, Multivariate Analysis, Validation, Troubleshooting, Sample Matrix Design

Industry

Biotechnology Research

Description

Do we belong together? CLADE builds analytical technologies for biopharma teams that need faster, simpler and more data-rich ways to characterise complex liquid samples. We are building the MIRA Evidence Lab to generate the scientific proof behind our product claims, customer workflows and product roadmap. This is not a routine QC role. It is a senior scientific role for someone who can design experiments, analyse data, compare MIRA against reference methods and turn results into evidence that Product, Data Science, Commercial and customers can trust. You will work at the interface of biologics analytics, spectroscopy, chemometrics and experimental design. You will be... Leading high-value evidence studies from initial scientific question through to final reporting. Designing experimental protocols, DoEs, sample matrices, controls, as well as robustness, stress, and comparator studies for priority MIRA workflows. Planning and analysing studies in biologics applications, including formulation analytics, excipient quantification, polysorbate analysis, protein concentration and structure, UF/DF, as well as stability and release-like workflows. Evaluating MIRA results against orthogonal and reference methods such as HPLC/UPLC, UV-Vis (A280), CD, pH/osmolality, CE, DLS/MALS, LC-MS, and external laboratory data. Analysing MIR/FTIR spectral and reference data to assess performance, reproducibility, robustness, uncertainty, and method limitations. Collaborating closely with Product and Data Science teams to translate evidence into improvements in instruments, software, models, and workflows. Preparing high-quality documentation, including protocols, study reports, evidence packages, application notes, technical notes, SOPs, and claim-support materials. Supporting customer-proof activities for validated workflows while maintaining a focused, evidence-driven intake approach. Coordinating external reference analytics when required. Contributing to the development of a scalable lab operating model ensuring every major claim is backed by defined protocols, reports, reference methods, and clearly stated limitations. You're a good fit for us if... You bring solid experience in pharma or biologics, which is essential for this role. You have several years of industry experience in pharma, biotech, CDMO, or related areas such as analytical development, QC, process analytics, formulation development, or biologics characterisation. You have hands-on experience working with biological or biopharmaceutical samples, including proteins, monoclonal antibodies (mAbs), bispecifics, ADCs, peptides, AAV/pDNA, or formulated drug products. You possess a strong understanding of analytical method development, including qualification, validation, transfer, troubleshooting, and documentation. You are able to independently design experiments, including defining sample matrices, controls, replicates, acceptance criteria, and statistical analysis plans. You have strong data analysis skills and can clearly interpret and communicate complex experimental results. You are familiar with GMP/GxP environments, including data integrity principles, SOPs, change control processes, deviations, and ICH-style approaches to analytical development and validation. You demonstrate excellent scientific writing skills in English. You hold a degree in analytical chemistry, biochemistry, biotechnology, pharmaceutical sciences, biophysics, or a related field; a PhD is preferred, though an MSc with strong and relevant industry experience is equally valued. Nice to have: Experience with MIR/FTIR, NIR, Raman, UV-Vis, CD,fluorescenceor other spectroscopic techniques. Experience with chemometrics or multivariate analysis, such as PCA, PLS, calibration, preprocessing, modeltransferand outlier analysis. Experience with biologics analytical methods such as SEC, IEX, RP-HPLC/UPLC, CE-SDS,cIEF, LC-MS, DLS, MALS, ELISA, A280, pH, osmolality, or surfactant and excipient assays. Experience with Python, R, JMP, MATLAB, GraphPadPrismor similar analysis tools. Experience with external reference labs, CROs,CDMOsor customer-facing technical projects. Experience withhigh-throughput analytics, autosamplers, LIMS/ELN or automated sample workflows. Scientific communication experience with customers, productteamsor commercial teams. That´s CLADE Our colleagues are bold, enabling, versatile and genuine. We support each other, dare to question ourselves and the status quo and we stay true to ourselves. If you find yourself in these values, then read to the end and get in touch with us directly. What makes us unique If you live near one of our offices and want to work locally, you always have a place to work, but you can also work mobile within Germany and Europe(up to 60 days per year). Our company consists of motivated, passionate and open-minded people with a great drive who want to develop together with you. Our in-house processes are sophisticated, unbureaucratic and simple and we are big fans of short decision-making paths Your onboarding is important to us, so you don't have to worry about anything in the first week, you get insights into all relevant topics. We offer a company pension scheme, a "300 EUR - Feel Free Health Budget" per year, a kindergarten allowance of up to 180 EUR per month, a monthly internet allowance, vouchers worth 20 EUR per month, bike leasing, electronics leasing subscription model and an attractive bonus model We live and love diversity, inclusion and internationality CLADEtivities: regular company-wide and also site-specific events await you Opportunity to participate in various committees and working groups If you have any questions about the position or the company, you can contact our people & culture team at any time at jobs@clade.io. If you want to learn more about us and our values, visit our homepage (www.clade.io), our LinkedIn channel ( https://www.linkedin.com/company/cladegmbh/) or Instagram channel (@peopleatclade). About us Results at the speed of excellence: CLADE offers a uniquely precise spectroscopy technology for a wide range of applications. This technology differs in its speed, efficiency and reproducibility compared to conventional complex laboratory analysis. Our product concept consists of a hardware component - our MIRA Analyzer, which performs chemical analysis in liquid environments using infrared spectroscopy within minutes. We can thus produce a digital fingerprint of a liquid in a short time. With our customized applications - our software component Sphere, we can selectively filter the acquired data using pattern recognition and algorithms and prepare it for further processing. In the last years our approach has remained constant in two regards. First, we always question the status quo and, second, we consistently go above and beyond what we expect of ourselves.

Responsibilities

Lead high-value evidence studies to validate product claims by designing experimental protocols and analyzing biologics data. Collaborate with Product and Data Science teams to translate results into instrument and software improvements.