Lead Process Scientist, Drug Product (Sr. Manager) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Takeda · 1 month ago

Lead Process Scientist, Drug Product (Sr. Manager)

Takeda is a leading global biopharmaceutical company focused on bringing better health and a brighter future to patients. The Lead Process Scientist will provide process science and manufacturing technology leadership for drug product manufacturing, acting as a technical SME and aligning cross-functional stakeholders to ensure robust and compliant manufacturing processes. This role involves overseeing technical deliverables, driving manufacturing strategies, and ensuring process knowledge is effectively shared across the organization.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

Lead and/or oversee DP technical deliverables across the product lifecycle, including:
Technology transfer to internal sites and external contract manufacturing organizations (CMOs)
Process validation planning and execution support
Process characterization and establishment of process understanding
Serve as an escalation point for complex technical investigations and issue resolution, mobilizing and coordinating rapid cross-site support when needed
Drive manufacturing strategies for assigned key products, ensuring the approach is consistent across Takeda’s internal network and CMOs and is grounded in process knowledge and science-based risk management
Lead continuous improvement for late-phase/matured products by identifying and advancing opportunities that improve robustness, control strategy, and operational performance without compromising compliance
Partner effectively in a matrix environment with key stakeholders, including:
Pharmaceutical Sciences counterparts (R&D)
Manufacturing site and operating unit leaders
Local Technical Services organizations
Global Quality and Regulatory CMC teams
Ensure process knowledge is captured, shared, and reused across sites and functions to strengthen Takeda’s overall DP manufacturing capability and speed decision-making

Qualification

Drug Product ManufacturingProcess ValidationTechnology TransferRegulatory CMC ReadinessPharmaceutical DevelopmentStakeholder ManagementContinuous ImprovementCommunication SkillsProblem Solving

Required

Degree (BS, MS, and/or PhD) in Chemistry, Chemical Engineering, or a related discipline (or equivalent combination of education and experience)
At least 5 years of relevant industry experience, with experience supporting pharmaceutical development and/or manufacturing in DP-related areas (e.g., OSD and/or parenterals)
Demonstrated success as an SME and project leader in a matrix environment, influencing technical decisions across functions and sites without relying on direct authority
Strong working knowledge of DP manufacturing technologies, validation and tech transfer principles, and practical application of industry best practices
Experience contributing to or leading regulatory CMC readiness, including converting process understanding into clear technical narratives and defensible control strategies
Proven ability to analyze complex problems, drive to root cause, and implement sustainable solutions with high technical rigor
Communication and stakeholder-management skills that enable effective collaboration, conflict resolution, and alignment across internal teams and external partners
A working style that prioritizes focus, accountability, and measurable outcomes, while actively building capability for the future

Benefits

U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Company

Takeda

twittertwittertwitter
company-logo
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.

H1B Sponsorship

Takeda 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
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)

Funding

Current Stage
Public Company
Total Funding
$2.46B
2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M

Leadership Team

leader-logo
Christophe Weber
President and CEO
linkedin
leader-logo
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
linkedin
Company data provided by crunchbase