Sr. Manager QC

1 month ago

Remote, Oregon, United States Immunovant Full time

Organizational Overview:

Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 3 clinical development is underway.

The Role:

Immunovant is seeking a Senior Manager, QC to provide quality oversight of Quality Control laboratory activities. The position directly reports to the Associate Quality Control / Director Stability with responsibility for leading all Quality Control activities related to product analytical testing, while ensuring compliance with global GxP regulations across multiple indications. This individual will have the unique opportunity to help grow and shape IMVT Quality, while establishing a compliant and collaborative partnership with Analytical Sciences and contracted Quality Control laboratories.

The Senior Manager, QC is responsible for managing quality control activities and will provide leadership and oversight of GMP testing at CMOs and contract testing laboratories. The individual should be knowledgeable in multiple analytical techniques pertaining to proteins and/or mAbs separations. This role involves significant vendor oversight, primary raw data review, exceptions management (deviations, CAPAs, OOS/OOT), and change control, so requires a strong knowledge and understanding of GMP-regulated quality systems as it pertains to both internal systems and external organizations.

This individual will work closely with other areas such as CMC Manufacturing, Quality Assurance, and CMC Regulatory Affairs to manage the manage key deliverables as it pertains to testing laboratories to ensure timelines coincide schedules and corporate goals. This individual will help ensure regulatory compliance with FDA, EMA, ROW, and other applicable global health authority requirements, as it pertains to laboratory testing activities.

The Senior Manager, QC will also participate in strategic planning with a focus on meeting corporate quality goals, promoting a culture of quality across the company, and ensuring a compliant culture of quality through effective management with strong adherence to Immunovant's key value pillars.

Key Responsibilities:

  • Oversee GMP testing at CMOs/ third party testing sites as it applies to Quality Control testing of raw materials, components, in-process, and drug substance.
  • Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory requirements.
  • Provide analytical oversight, facilitation, and leadership for OOS investigations, change controls, deviations, CAPAs, risk assessments, and continuous improvement initiatives.
  • Verify/review analytical source data to ensure data integrity, traceability, and compliance during review of all analytical documentation required for the release of product.
  • Ensure adequate phase-specific qualification and validation of analytical QC test methods in collaboration with Analytical Development, through oversight and collaboration, and data/document review of associated protocols/reports.
  • Manage technology transfers and method improvements needed to assure reliable, robust, fit for purpose, and cGMP compliant methods are implemented at the testing laboratories.
  • Review and approve sampling instructions, test methods, specifications, stability protocols, and other Quality Control procedures.
  • Drive product quality through effective virtual QC systems, provide supplier oversight with adequate surveillance.
  • Ensure contracted third-party testing laboratories follow appropriate quality and regulatory practices and participates in regulatory inspections and third-party audits, as needed.
  • Encourage an environment for 'Quality Right First Time' by building in efficiencies as necessary from a systematic and compliance perspective.
  • Perform additional Quality-related duties as assigned.

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 managing third party laboratories is essential.
  • 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.
  • Experience with reference standard management is a plus.
  • Ability to independently resolve technical issues; effectively lead teams with internal and external SMEs to solve issues with broad scope and/or high complexity.
  • 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.
  • Knowledge of statistics including the use of JMP software is preferred.
  • MS Office applications, Veeva QualityDocs, Empower, LIMS, is desired.

Work Environment

  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Remote-based; will have access to Immunovant's NYC/NC offices.
  • Domestic travel required (up to 15%)

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