Senior Manager, QC

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Immunovant

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2018

🏥 Gesundheitswesen

🧬 Biotechnologie

💊 Pharmazie

Healthcare • Biotechnology • Pharmaceuticals

Immunovant ist ein Unternehmen, das sich darauf konzentriert, Behandlungen für Autoimmunerkrankungen mit einem patientenzentrierten Ansatz voranzutreiben. Mit der Vision, Menschen mit Autoimmunerkrankungen ein normales Leben zu ermöglichen, nutzt Immunovant seine Expertise in der Wissenschaft, um neue Therapien zu entwickeln und zu testen. Das Unternehmen legt Wert auf die komplexen und variablen Bedürfnisse in verschiedenen Stadien und Schweregraden von Krankheiten. Immunovant engagiert sich dafür, seine therapeutischen Bereiche und klinischen Studien voranzutreiben, während es gleichzeitig den Austausch mit Patienten, Pflegekräften und Investoren über laufende Studien und Unternehmensinitiativen fördert.

Beschreibung

• 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.

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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.