TAKEDA PHARMACEUTICALS AMERICA, INC. · 1 month ago
Senior Manager, Commercial Biologics Product Science Lead
Vienna, MI
Full-time
Onsite
Senior Level, Lead/Staff
$137K/yr - $215K/yr
10+ years expTakeda Pharmaceuticals America, Inc. is seeking a Senior Manager for their global Biologics Product Sciences team. In this role, you will provide technical expertise and leadership for regulatory interactions and ensure robust control strategies for Takeda’s diverse commercial biologics portfolio.
Pharmaceuticals
Responsibilities
Build and maintain a comprehensive understanding of product structure, critical quality attributes, impurities, stability and structure–function relationships
Define and justify product specifications using process and analytical history, ensuring consistency across sites and over the product lifecycle
Design and own analytical comparability strategies and non‑GMP analytical methods for assigned products
Lead preparation and review of CMC dossier sections related to product quality, characterization and analytical control strategy
Provide technical leadership for complex investigations and cross-site initiatives affecting product quality, driving alignment and timely decision-making
Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical Sciences, Global Manufacturing Sciences and Quality
Ensure effective product knowledge sharing across sites and functions to support reliable commercial supply
Influence stakeholders across functions and regions to resolve complex issues, balancing patient, quality, business and regulatory considerations
Mentor colleagues and contribute to the development of future talent in biologics product sciences
Qualification
Required
Degree in Engineering, Life Sciences, or closely related area
B.Sc. with a minimum of 10 years of experience in a pharma/biotech environment
Deep expertise in analytical methods and characterization for biologics with capability and interest in analyzing and solving complex problems through innovative thought and experience
Experience with activities associated with commercial launch and release as well as interactions with Health Authorities to support submissions
Clear, concise communication skills, with the ability to convey complex concepts in writing and in person to technical and non-technical audiences
Demonstrated enterprise mindset, strong prioritization and quality focus
Fluent English required
Preferred
An advanced degree (M.Sc. or PhD) is preferred
Experience operating globally in a matrixed organization would be greatly appreciated
Proficiency in verbal and written Mandarin is beneficial but not required
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
TAKEDA PHARMACEUTICALS AMERICA, INC.
TAKEDA PHARMACEUTICALS AMERICA, INC.
10001+ employees
H1B Sponsorship
TAKEDA PHARMACEUTICALS AMERICA, INC. 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
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Trends of Total Sponsorships
2025 (6)
2024 (7)
2023 (9)
2022 (1)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Catherine Fintzel MBA PMP
Sr. Business Partner
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