Immunovant · 1 day ago
Associate Director, Analytical Sciences and Technology
United States
Full-time
Remote
Lead/Staff, Director/Executive
$175K/yr - $185K/yr
4+ years expImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. The Associate Director, Analytical Sciences role is responsible for managing analytical development activities at contract testing laboratories, ensuring compliance with regulatory requirements, and implementing analytical strategies for product testing.
BiopharmaBiotechnologyPharmaceutical
Hiring Manager
Mohammad Ouranus
Responsibilities
Provides analytical oversight and approval of cGMP documents (change controls, deviations, CAPAs, method qualification and validation protocols and reports, transfer protocols, justification of specifications, etc.)
Implementation and life-cycle management of methods for testing raw materials, components, drug substance and drug product
Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory requirements
Author relevant CMC sections for regulatory submission documents
Coordinate and/or participate in projects related to analytical responsibilities and propose improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies
Work alongside analytical characterization (subject matter) expert and support protocol, data, and report review and finalization
Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to Immunovant; work to remediate any identified gaps
Maintain an active analytical risk register compliant with current Quality Risk Management practices
Qualification
Required
Bachelor of Science in biology/chemistry/biochemistry field and 6 years (or MS with 5 years, PhD with 4 years) of experience in biopharmaceutical analytical and/or QC operations for development through commercial products
Experience with development, transfer, and validation activities are Demonstrated history of methods continuous improvement is desired
This role will involve oversight of method development, method validation and support GMP testing at CMOs/ contract test laboratories as it applies to laboratory and stability
Strong organizational and communication skills
Experience with, and a good understanding of, FDA and other key regulatory agency regulations and guidance including ICH guidance documents, is required
Full understanding of GMPs and the pharmaceutical development process is required, as well as transfer of processes and methods from development to clinical manufacturing to commercialization is necessary
Broad knowledge of risk-based Quality Systems' components including Quality Risk Management is required
Preferred
Experience in biologics including monoclonal antibodies is highly preferred
Knowledge of antibody structure and heightened analytical characterization methods is highly preferred
Demonstrated experience effectively managing projects with contract testing laboratories is highly preferred
Knowledge of statistics including the use of JMP software is preferred
MS Office applications, Veeva QMS, Oracle, Empower, LIMS is highly preferred
Benefits
Medical
Dental
Vision
401k
Unlimited paid time off
Parental leave
Company
Immunovant
Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases.
201-500 employees
H1B Sponsorship
Immunovant has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.86BKey Investors
Roivant Sciences
2025-12-11Post Ipo Equity· $550M
2025-01-13Post Ipo Equity· $450M
2023-09-27Post Ipo Equity· $450M
Leadership Team
Melanie Gloria
COO
Recent News
MarketScreener
2026-01-05
Investor's Business Daily
2025-12-16
Company data provided by crunchbase