CMC Analytical Lead

{
  "content_hash": "f25ac6ac23320f446ff489c716ede5fcf2917cf26716c9d7c926242e20f51ab9",
  "source_hash": "1a66264eba532678c4af60e4374be837c0772734f20930dfcfcd8e1c17592009",
  "last_changed_at": "2026-06-04T12:42:01.650Z",
  "active_status": "active"
}

{
  "language": "en",
  "location": {
    "raw": "London",
    "city": null,
    "region": null,
    "country": "London",
    "is_remote": false,
    "confidence": 0.8
  },
  "salary_max": null,
  "salary_min": null,
  "inferred_at": "2026-06-06T07:57:57.196Z",
  "launch_scope": {
    "reason": "personio_production_catalog",
    "included": true,
    "location": {
      "raw": "London",
      "city": null,
      "region": null,
      "country": "London",
      "is_remote": false,
      "confidence": 0.8
    },
    "countries": [
      "London"
    ]
  },
  "remote_policy": null,
  "salary_period": null,
  "workplace_type": null,
  "salary_currency": null
}

{}

{
  "id": "2655116",
  "name": "CMC Analytical Lead",
  "office": "London",
  "keywords": [],
  "schedule": "full-time",
  "createdAt": "2026-06-02T15:59:25+00:00",
  "seniority": "experienced",
  "department": "CMC",
  "occupation": "general_and_other_r_and_d_and_science",
  "subcompany": null,
  "employmentType": "permanent",
  "jobDescriptions": [
    {
      "name": "Your mission",
      "value": "We are seeking an experienced Analytical CMC Lead to provide technical leadership for analytical activities supporting Engitix’s early-stage development programs. This role will lead analytical CMC activities, with responsibility for method development and validation, clinical release and stability, control strategy, and IND-enabling activities.<br><br>Experience supporting biologics programs is required, and experience with Antibody-Drug Conjugates (ADCs) is highly desirable.<br><br><strong>Key Responsibilities:</strong><br><ul><li>Lead analytical CMC activities for early-stage biologics and/or ADC programs, with oversight of analytical development and QC activities at CDMOs and external laboratories</li><li>Serve as the primary analytical lead for CDMO interactions, managing technical execution, timelines, deliverables, and cross-functional coordination across CMC, quality, regulatory, manufacturing, and clinical supply teams</li><li>Oversee analytical method development, qualification, transfer, and lifecycle management for drug substance and drug product programs</li><li>Provide analytical oversight of QC activities including release and stability testing, characterization, reference standards, investigations, deviations, and change controls</li><li>Develop phase-appropriate analytical control strategies, including specification setting and justification, to support clinical development and regulatory requirements</li><li>Lead stability strategy and data review to support shelf-life and retest period assignments</li><li>Review analytical data to support process development, comparability, process characterization, investigations, and regulatory submissions</li><li>Author and review analytical CMC sections for INDs and other regulatory submissions, including specifications, analytical methods, qualification/validation summaries, comparability, and stability documentation</li><li>Support regulatory interactions and ensure analytical activities comply with GMP, ICH, and global regulatory expectations</li><li>Identify analytical and operational risks related to external execution and implement mitigation strategies to support program timelines and milestones</li></ul>"
    },
    {
      "name": "Your profile",
      "value": "<ul><li>Advanced degree (M.S., Ph.D.) in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline preferred</li><li>8+ years experience in analytical development within biologics, large molecule, or bioconjugate CMC environments, or equivalent</li><li>Strong expertise in analytical characterization techniques for proteins and biologics</li><li>Experience overseeing QC testing, analytical outsourcing, and CDMO management</li><li>Demonstrated experience with analytical method development, qualification, transfer, and troubleshooting</li><li>Experience supporting stability programs, specification setting, and control strategy development</li><li>Working knowledge of early-phase regulatory expectations and IND-enabling activities</li><li>Experience authoring and reviewing analytical sections of IND submissions</li><li>Experience with ADCs is a strong plus</li><li>Experience with small-molecule analytics, including linker-payload characterization, is a plus</li><li>Strong project management, communication, and cross-functional collaboration skills</li></ul>"
    },
    {
      "name": "Why us?",
      "value": "<ul><li>Be part of a pioneering biotech transforming drug discovery through ECM biology</li><li>Work in a collaborative, fast-paced environment with opportunities to shape the future of targeted therapeutics</li><li>We offer a competitive package including private medical insurance, pension, bonus, employee perks and more</li></ul>"
    }
  ],
  "occupationCategory": "r_and_d_and_science",
  "recruitingCategory": "Permanent Employee"
}