Biotech manufacturing is built on living systems rather than pure chemical synthesis. Upstream processing grows cell lines or microbial cultures in bioreactors under tightly controlled temperature, pH and dissolved-oxygen conditions; downstream processing then purifies the target molecule (monoclonal antibody, vaccine antigen, recombinant protein) through chromatography, filtration and viral clearance steps.
Because the product is biological, quality control leans heavily on bioassays (ELISA, cell-based potency assays) rather than simple chemical analysis, and batch-to-batch biological variability makes documentation and process consistency even more critical than in conventional pharma. Regulatory pathways for biologics and biosimilars (BLA, WHO prequalification) are also distinct from small-molecule drug approval.
Biotech roles split cleanly along the upstream/downstream bioprocess line, plus emerging specializations like cell & gene therapy. This is the functional map we recruit against.
Genomics, protein engineering and cell line development that feed into a manufacturable biologic.
Fermentation or mammalian cell culture in bioreactors, with media and feed optimization for yield.
Purification via chromatography, filtration and viral clearance to isolate the target biologic.
Fill-finish operations, single-use system management and GMP batch documentation for biologics.
Potency and identity testing via bioassays (ELISA, cell-based assays) and biologics batch release.
BLA filings, biosimilar regulatory pathway strategy and WHO prequalification submissions.
Computational analysis of sequencing and process data supporting cell line and process development.
Viral vector production, cell therapy manufacturing and cryopreservation logistics for advanced therapies.
We know the difference between bench-scale and production-scale bioprocess experience, and screen for the one your plant actually needs.
We source QC candidates who understand biological assay variability, not just chemical analytical testing.
Our regulatory affairs shortlists are filtered for actual BLA/biosimilar filing exposure, not adjacent small-molecule experience.
Given how talent-scarce cell & gene therapy roles are, we start sourcing conversations well ahead of your hiring deadline.
Talk to a recruiter who already understands the function, the compliance load and the talent pool.
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