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


Responsibilities
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