Vibrant Sciences
Analytical Scientist – Monoclonal Antibody Characterization
Location: Lab-Based (Santa Clara, CA)
Company Overview At Immune Balance, a leading biopharmaceutical company specializing in monoclonal antibodies (mAbs) for immunology and autoimmune therapeutics, we are committed to advancing innovative treatments through rigorous quality assurance. Our team develops and manufactures high‑quality mAbs to ensure efficacy, safety, and consistency in compliance with FDA, EMA, and ICH guidelines.
Position Summary The Analytical Scientist will conduct hands‑on analytical measurements on monoclonal antibodies to evaluate critical, moderate, and low‑risk CQAs. This lab‑based role involves executing gold‑standard assays for structural, biochemical, biophysical, and functional analyses during transient expression, cell line development, and process development phases. The ideal candidate will ensure product quality, stability, and regulatory compliance through precise method execution and data interpretation.
Key Responsibilities
Perform amino acid sequencing using LC‑MS/MS to verify sequence integrity and detect variants.
Analyze disulfide bonds via LC‑MS/MS disulfide mapping to ensure structural stability.
Assess higher‑order structure with CD, DSC, HDX‑MS, and NMR to confirm folding and conformation.
Evaluate aggregation using SEC‑HPLC and AUC to prevent immunogenicity risks.
Conduct potency/bioassay with SPR or ELISA to measure biological activity.
Profile N‑linked glycans and sialylation via HILIC‑UPLC and RP‑HPLC/MS to ensure consistent glycosylation.
Detect oxidation at critical sites using peptide mapping LC‑MS/MS to maintain product stability.
Characterize charge variants with iCIEF or CEX‑HPLC to monitor isoforms.
Measure deamidation at critical sites with LC‑MS/MS peptide mapping to assess stability.
Determine fucosylation by HILIC‑UPLC/FLR to evaluate functional activity.
Analyze C‑terminal lysine with CEX‑HPLC to check processing completeness.
Assess other glycan heterogeneity using HILIC‑UPLC to ensure product consistency.
Determine thermal stability/Tm with DSC to predict shelf life.
Quantify host cell protein using polyclonal HCP ELISA to ensure purity.
Detect residual DNA with ddPCR to comply with safety limits.
Identify product‑related variants (oxidation, isomerization) with CEX‑HPLC, SEC‑HPLC, and HILIC‑HPLC.
Evaluate oligomeric state with SEC‑MALS to confirm monomeric form.
Test solubility with spectrophotometer and SEC‑HPLC to ensure formulation viability.
Assess appearance (color, clarity) with visual inspection and spectrophotometer to meet USP standards.
Measure pH with glass pH meter and osmolality with freezing point depression osmometer to ensure stability.
Quantify excipient content with HPLC‑MS/IC to verify formulation.
Analyze non‑critical glycation with LC‑MS/MS to monitor minor modifications.
Detect non‑critical PTMs with peptide mapping LC‑MS/MS to ensure product uniformity.
Measure viscosity with rheometer to optimize injection.
Count sub‑visible particulates with micro flow imaging to meet USP
standards.
Profile isoform distribution with CEX‑HPLC, iEF, LC‑MS, and HILIC for charge heterogeneity.
Test endotoxin with LAL assay to ensure
Monitor stability under storage with assay panel (SEC‑HPLC/Potency) to predict shelf life.
Collaborate with R&D, QC, and manufacturing teams to interpret data and recommend process improvements.
Maintain GLP/GMP compliance, document protocols, and prepare reports for regulatory submissions (e.g., IND, BLA).
Required Qualifications
MS or PhD in Biochemistry, Analytical Chemistry, or related field; BS with 5+ years experience considered.
3+ years in biopharmaceutical analytics, preferably with mAbs or biologics.
Hands‑on experience with LC‑MS/MS, HPLC (RP, SEC, HILIC, CEX), DSC, NMR, SPR, ELISA, ddPCR, and LAL assay.
Knowledge of CQAs for mAbs per ICH Q8/Q9/Q10 and USP/EP standards.
Proficiency in data analysis software (e.g., Empower, MassHunter, Chromeleon).
Strong understanding of protein chemistry, glycosylation, and stability.
Preferred Skills
Experience with monoclonal antibodies in immunology/autoimmune therapeutics.
Certification in GLP/GMP or bioassay validation.
Familiarity with FDA/EMA regulations for biologics.
Ability to troubleshoot assays and optimize methods.
Excellent communication for cross‑team collaboration.
Salary USD 146,540.00–189,640.00 (San Francisco Bay Area)
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Company Overview At Immune Balance, a leading biopharmaceutical company specializing in monoclonal antibodies (mAbs) for immunology and autoimmune therapeutics, we are committed to advancing innovative treatments through rigorous quality assurance. Our team develops and manufactures high‑quality mAbs to ensure efficacy, safety, and consistency in compliance with FDA, EMA, and ICH guidelines.
Position Summary The Analytical Scientist will conduct hands‑on analytical measurements on monoclonal antibodies to evaluate critical, moderate, and low‑risk CQAs. This lab‑based role involves executing gold‑standard assays for structural, biochemical, biophysical, and functional analyses during transient expression, cell line development, and process development phases. The ideal candidate will ensure product quality, stability, and regulatory compliance through precise method execution and data interpretation.
Key Responsibilities
Perform amino acid sequencing using LC‑MS/MS to verify sequence integrity and detect variants.
Analyze disulfide bonds via LC‑MS/MS disulfide mapping to ensure structural stability.
Assess higher‑order structure with CD, DSC, HDX‑MS, and NMR to confirm folding and conformation.
Evaluate aggregation using SEC‑HPLC and AUC to prevent immunogenicity risks.
Conduct potency/bioassay with SPR or ELISA to measure biological activity.
Profile N‑linked glycans and sialylation via HILIC‑UPLC and RP‑HPLC/MS to ensure consistent glycosylation.
Detect oxidation at critical sites using peptide mapping LC‑MS/MS to maintain product stability.
Characterize charge variants with iCIEF or CEX‑HPLC to monitor isoforms.
Measure deamidation at critical sites with LC‑MS/MS peptide mapping to assess stability.
Determine fucosylation by HILIC‑UPLC/FLR to evaluate functional activity.
Analyze C‑terminal lysine with CEX‑HPLC to check processing completeness.
Assess other glycan heterogeneity using HILIC‑UPLC to ensure product consistency.
Determine thermal stability/Tm with DSC to predict shelf life.
Quantify host cell protein using polyclonal HCP ELISA to ensure purity.
Detect residual DNA with ddPCR to comply with safety limits.
Identify product‑related variants (oxidation, isomerization) with CEX‑HPLC, SEC‑HPLC, and HILIC‑HPLC.
Evaluate oligomeric state with SEC‑MALS to confirm monomeric form.
Test solubility with spectrophotometer and SEC‑HPLC to ensure formulation viability.
Assess appearance (color, clarity) with visual inspection and spectrophotometer to meet USP standards.
Measure pH with glass pH meter and osmolality with freezing point depression osmometer to ensure stability.
Quantify excipient content with HPLC‑MS/IC to verify formulation.
Analyze non‑critical glycation with LC‑MS/MS to monitor minor modifications.
Detect non‑critical PTMs with peptide mapping LC‑MS/MS to ensure product uniformity.
Measure viscosity with rheometer to optimize injection.
Count sub‑visible particulates with micro flow imaging to meet USP
standards.
Profile isoform distribution with CEX‑HPLC, iEF, LC‑MS, and HILIC for charge heterogeneity.
Test endotoxin with LAL assay to ensure
Monitor stability under storage with assay panel (SEC‑HPLC/Potency) to predict shelf life.
Collaborate with R&D, QC, and manufacturing teams to interpret data and recommend process improvements.
Maintain GLP/GMP compliance, document protocols, and prepare reports for regulatory submissions (e.g., IND, BLA).
Required Qualifications
MS or PhD in Biochemistry, Analytical Chemistry, or related field; BS with 5+ years experience considered.
3+ years in biopharmaceutical analytics, preferably with mAbs or biologics.
Hands‑on experience with LC‑MS/MS, HPLC (RP, SEC, HILIC, CEX), DSC, NMR, SPR, ELISA, ddPCR, and LAL assay.
Knowledge of CQAs for mAbs per ICH Q8/Q9/Q10 and USP/EP standards.
Proficiency in data analysis software (e.g., Empower, MassHunter, Chromeleon).
Strong understanding of protein chemistry, glycosylation, and stability.
Preferred Skills
Experience with monoclonal antibodies in immunology/autoimmune therapeutics.
Certification in GLP/GMP or bioassay validation.
Familiarity with FDA/EMA regulations for biologics.
Ability to troubleshoot assays and optimize methods.
Excellent communication for cross‑team collaboration.
Salary USD 146,540.00–189,640.00 (San Francisco Bay Area)
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