QC Analytical Scientist

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  "source_hash": "214a26b41c5bd0201379b49dd61ab04619aa4299a9686c87d50bd3026f597f14",
  "last_changed_at": "2026-06-03T12:27:01.776Z",
  "active_status": "active"
}

{
  "language": "en",
  "location": {
    "raw": "Emeryville, CA",
    "city": "Emeryville",
    "region": "CA",
    "country": "United States",
    "is_remote": false,
    "confidence": 0.9
  },
  "salary_max": 170000,
  "salary_min": 140000,
  "inferred_at": "2026-06-06T20:02:59.568Z",
  "launch_scope": {
    "reason": "english_us_canada",
    "included": true,
    "language": "en",
    "location": {
      "raw": "Emeryville, CA",
      "city": "Emeryville",
      "region": "CA",
      "country": "United States",
      "is_remote": false,
      "confidence": 0.9
    },
    "countries": [
      "United States"
    ]
  },
  "remote_policy": null,
  "salary_period": "year",
  "workplace_type": "on_site",
  "salary_currency": "USD"
}

{}

{
  "lists": [
    {
      "text": "Qualifications",
      "content": "\n<li>PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field</li>\n<li>8–15+ years of relevant experience in biotech, pharma, or CRO environments</li>\n<li>Demonstrated expertise in bioanalytical method development, validation, and data interpretation</li>\n<li>Strong understanding of both:\n\n</li><li>Ligand-binding assays (e.g., ELISA, MSD)</li>\n<li>LC-MS/MS-based quantitation (hands-on experience not required, but deep conceptual understanding is essential)</li>\n\n\n<li>Experience overseeing and critically evaluating CRO-generated data</li>\n<li>Working knowledge of GLP bioanalysis and regulatory expectations (e.g., ICH M10)</li>\n<li>Solid grounding in pharmacokinetics and interpretation of concentration–time data</li>\n\n<div>Preferred Qualifications</div>\n\n<li>Experience across multiple molecular modalities (peptides, monoclonal antibodies, small molecules)</li>\n<li>Background in analytical development or QC for regulated products</li>\n<li>Experience supporting IND-enabling studies or clinical programs</li>\n<li>Familiarity with complex or long-acting drug delivery systems</li>\n"
    },
    {
      "text": "",
      "content": "\n<li>Own bioanalytical strategy\n\n</li><li>Define fit-for-purpose analytical approaches for PK, PD, and mechanistic studies</li>\n<li>Select appropriate assay platforms (ligand-binding, LC-MS-based, hybrid methods)</li>\n\n\n<li>Lead CRO oversight\n\n</li><li>Design and manage outsourced bioanalytical studies</li>\n<li>Critically review assay development, validation, and sample analysis</li>\n<li>Identify deficiencies in methods, data quality, or interpretation and drive resolution</li>\n\n\n<li>Ensure quantitative rigor and data integrity\n\n</li><li>Evaluate calibration models, LLOQ, accuracy/precision, and assay robustness</li>\n<li>Detect and troubleshoot issues such as matrix effects, instability, adsorption, and assay interference</li>\n<li>Establish internal standards for data quality across programs</li>\n\n\n<li>Apply QC and regulatory principles\n\n</li><li>Ensure methods and datasets meet GLP and regulatory expectations (e.g., ICH M10)</li>\n<li>Contribute to analytical sections of IND-enabling packages and regulatory filings</li>\n<li>Implement quality systems and documentation standards where needed</li>\n\n\n<li>Support cross-functional decision making\n\n</li><li>Work closely with PK/PD, biology, and clinical teams to interpret data correctly</li>\n<li>Distinguish analytical artifacts from true biological signals</li>\n<li>Provide clear recommendations based on quantitative evidence</li>\n\n\n<li>Operate across modalities\n\n</li><li>Apply consistent analytical thinking across peptides, biologics, and small molecules</li>\n<li>Ensure comparability and continuity of data across platforms and studies</li>\n\n\n"
    }
  ],
  "country": "US",
  "createdAt": 1780419677626,
  "updatedAt": null,
  "categories": {
    "team": "4:59 - Prolynx",
    "location": "Emeryville, CA",
    "commitment": "Full-time",
    "department": "4:59 Initiative",
    "allLocations": [
      "Emeryville, CA"
    ]
  },
  "salaryRange": {
    "max": 170000,
    "min": 140000,
    "currency": "USD",
    "interval": "per-year-salary"
  },
  "workplaceType": "onsite"
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