Senior Scientist, Laboratory QA

Immunovant

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $170,000 - $180,000 per year

Job Level

Senior

About the role

  • Provide quality oversight of laboratory activities for analytical testing and ensure compliance with global GxP regulations
  • Provide leadership and oversight of GMP testing at CMOs and contract testing laboratories
  • Vendor oversight, review and approval of method validation, method transfer and stability documents, primary raw data review, exceptions management (deviations, CAPAs, OOS/OOT), and change control
  • Work closely with CMC Manufacturing, Quality Control, CMC QA, and CMC Regulatory Affairs to manage testing laboratory deliverables and timelines
  • Ensure regulatory compliance with FDA, EMA, ROW, and other global health authority requirements related to laboratory testing
  • Participate in strategic planning to meet corporate quality goals and promote a culture of quality across the company
  • Participate in regulatory inspections and third-party audits as needed
  • Review and approve sampling instructions, test methods, specifications, stability protocols, and QC procedures
  • Drive product quality through virtual Quality systems, supplier oversight, surveillance and KPI collection

Requirements

  • Bachelor (B.S.) or advanced degree in Biology, Chemistry, or related fields and 6 years (or MS with 5 years, PhD with 4 years) of experience in biopharmaceutical analytical and/or QC operations
  • Experience working with monoclonal antibody products desirable
  • Demonstrated experience effectively working with third party laboratories
  • Strong understanding of analytical GMP regulations governed by global health authority markets including FDA, EMA, and ROW
  • Knowledge of proteins and/or mAbs separations such as multiple modes for HPLC and capillary electrophoresis (e.g., SEC, RP-HPLC/UPLC, IEX, icIEF, CE-SDS) Protein Simple Maurice iCIEF and CE-SDS systems is desired
  • Knowledge of other analytical methodologies such ELISAs and other binding assays, impurity assays such as detection of host cell proteins, residual impurities, and peptide-mapping based on project needs, is preferred
  • Experience in qualification of analytical / microbiology method transfer and validation following ICH guidelines is desired
  • Strong knowledge, understanding and experience working in GMP-regulated quality environments and systems (e.g., document control, deviations/complaints, change control, DS/DP product release, CAPAs) with CMO partners
  • Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment
  • Ability to take initiative, prioritize and execute tasks with minimal direction or supervision, maintaining a high-level of integrity
  • Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants)
  • Strong analytical and organizational skills, with attention to detail
  • Excellent written, verbal, listening and interpersonal communication skills
  • MS Office applications, Veeva QualityDocs, Empower, LIMS, is desired