Senior Analytical Scientist-Biologics Evidence Lab (all genders)
at
CLADE GmbH
berlin, Berlin, Germany
-
Full Time
Start Date
Immediate
Expiry Date
29 Nov, 26
Salary
0.0
Posted On
31 Aug, 26
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
Yes
Skills
Industry
Pharmaceutical Manufacturing
Description
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