Otsuka Pharmaceutical Companies (U.S.) · 3 months ago
Associate Director, MSAT - Analytical Sciences (Biologics)
United States
Full-time
Remote
Lead/Staff, Director/Executive
$169K/yr - $253K/yr
8+ years expOtsuka Pharmaceutical Companies (U.S.) is a leading pharmaceutical company seeking an Associate Director of MSAT – Analytical Sciences. This role will serve as a scientific and technical leader supporting tech transfer and commercial manufacturing of biologic drug substances and products, overseeing analytical lifecycle management and method qualification/validation.
HealthcareHealth CareMedical
Responsibilities
Lead the analytical sciences function within MSAT to ensure robust support for commercial manufacturing of biologics (e.g., mAbs, fusion proteins)
Drive analytical control strategy, specification setting, and lifecycle management in alignment with QbD principles
Oversee method performance monitoring and trending, analytical capability assessments, and continuous improvement initiatives
Provide analytical subject matter expertise (SME) during technology transfers to external manufacturing sites
Support manufacturing investigations by leading root‑cause analyses, interpreting analytical data, and defining corrective and preventive actions
Guide method troubleshooting, resolution of OOS/OOT trends, and process–product linkages (CQA–CPP relationships)
Lead analytical method qualification/validation strategy to meet Phase‑appropriate and commercial requirements
Author, review, and approve analytical sections of regulatory filings (BLA/MAA, responses to agency queries)
Partner with QA, Regulatory, and MSAT to ensure compliance with global regulatory guidelines (ICH Q2, Q6B, Q14, etc.)
Partner closely with Process Development, Quality Control, Quality Assurance, Regulatory teams
Drive analytical readiness for tech transfers, PPQ readiness, comparability assessments, and lifecycle changes
Lead external oversight of CDMOs/CROs, ensuring analytical deliverables, timelines, and quality expectations are met
Ensure data integrity and proper scientific documentation across MSAT analytical activities
Qualification
Required
PhD or MS in Analytical Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or related field
8 + years (PhD) or 12+ years (MS) of experience in analytical development, QC, or MSAT for biologics
Demonstrated technical expertise in analytical methods for biologics (e.g., HPLC/UPLC, CE, LC‑MS, bioassays, ELISA, spectroscopy)
Strong experience in commercial biologics manufacturing support, tech transfer, and method lifecycle management
Deep knowledge of global regulatory expectations for biologics (ICH Q5, Q6, Q8, Q14; FDA and EMA guidance's)
Proven leadership skills and experience managing teams or cross‑functional technical groups
Experience with commercial biologics PPQ and BLA/MAA submissions
Expertise in statistical tools (e.g., JMP, Minitab) and digital data systems (e.g., LIMS)
Experience working with CDMOs/CROs and external manufacturing partners
Strong understanding of CQAs, control strategy development, and analytical–process integration
Benefits
Comprehensive medical, dental, vision, prescription drug coverage
Company provided basic life
Accidental death & dismemberment
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
A generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
H1B Sponsorship
Otsuka Pharmaceutical Companies (U.S.) 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
31%
Represents job field similar to this job
Engineering and Development
Management and Executive
Product Management
Accounting and Finance
Marketing
Sales
Customer Service and Support
Trends of Total Sponsorships
*2026 (3)
2025 (8)
2024 (6)
2023 (11)
2022 (5)
2021 (9)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
Recent News
2026-03-25
Company data provided by crunchbase