Senior Manager, QC

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Immunovant

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

📋 Description

• 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.

🎯 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 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

🏖️ Benefits

• 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.