Senior Scientist, Laboratory QA

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

Immunovant is seeking a Senior Scientist, Laboratory QA to provide quality oversight of laboratory activities. The position directly reports to the Vice-President, Laboratory Quality with responsibility for providing quality oversight for analytical activities related to 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 Scientist, Laboratory QA is responsible for ensuring compliance for analytical laboratory 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, review and approval of method validation, method transfer and stability documents, primary raw data review, exceptions management (deviations, CAPAs, OOS/OOT), and change control.  This position 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 Control, CMC QA, and CMC Regulatory Affairs to manage the 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 Scientist, Laboratory QA 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: 

• 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.
• Provide quality support, 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.
• Review and approve sampling instructions, test methods, specifications, stability protocols, and other Quality Control procedures.
• Drive product quality through effective virtual Quality systems, provide supplier oversight with adequate surveillance and collection of KPIs.
• Ensure contracted third-party testing laboratories follow appropriate quality and regulatory practices and participate 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 working with 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.
• 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.

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%)

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.