Senior Manager, QC

🕒 Julho 15

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $165.000 - $185.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

👻 Score fantasma 2%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Immunovant

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2018

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Immunovant é uma empresa focada no avanço de tratamentos para doenças autoimunes através de uma abordagem centrada no paciente. Com a visão de permitir vidas normais para pessoas com doenças autoimunes, a Immunovant aplica sua expertise em ciência para desenvolver e testar novas terapias. A empresa enfatiza as complexas e variadas necessidades em diferentes estágios e severidades das doenças. A Immunovant está comprometida em avançar suas áreas terapêuticas e ensaios clínicos, além de dialogar com pacientes, cuidadores e investidores sobre seus estudos em andamento e iniciativas corporativas.

Descrição

• 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. • 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 ensure reliable, robust, fit for purpose, and cGMP compliant methods are implemented at the testing laboratories. • Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory • Provide analytical oversight, facilitation, and leadership for OOS investigations, change controls, deviations, CAPAs, risk assessments, and continuous improvement initiatives. • 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. • Assure all applicable laboratory quality processes are deployed within IMVT and maintained in accordance with GMP, policies, and procedures. • Monitors and assesses emerging Quality and Regulatory requirements/issues and determines impact to Immunovant and works to remediate any identified gaps. • 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.

🎯 Requisitos

• 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 is desirable. • Demonstrated experience effectively managing third party laboratories is • 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 • 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 • Knowledge of statistics including the use of JMP software is • MS Office applications, Veeva Quality Docs, Empower, LIMS, is

🏖️ Benefícios

• 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.