Takeda · 10 hours ago
Head, Biotherapeutics Process Development (BPD)
Takeda is a global biopharmaceutical company focused on discovering and delivering innovative medicines. They are seeking a Head of Biotherapeutics Process Development (BPD) to set the vision and strategy for the BPD organization, overseeing the development and commercialization of biotherapeutics while leading a diverse global team.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Set and execute the global vision and strategy for end‑to‑end bioprocess development (cell line development, upstream, downstream) to enable the biologics portfolio from early development through commercial lifecycle
Direct and indirect supervisory responsibilities in one or more technical areas for development and manufacturing of high-quality biologic therapeutics
Partner closely with the leaders of Analytical development, Drug Product Development, Manufacturing, Quality and Regulatory functions to ensure the clinical products are manufactured with a high degree of quality and drive the global strategy for continuous and phase-appropriate process optimization in collaboration with stakeholders
Establish, maintain and govern global standards, policies, and best practices in biotherapeutic process development, including data integrity, knowledge management, and scientific/technical governance
Manage budgets, resources, and capacity within given limits to meet business goals, aligning investment and headcount with portfolio priorities, and overseeing external collaborations, licensing, and strategic vendor relationships
Establish and govern global standards and best practices, including technical guidance documents, data integrity expectations, knowledge management processes, and scientific review/decision forums
Ensure successful technology transfer and late-stage process characterization, validation, and control strategy definition to support regulatory submissions, pre-approval inspections, and lifecycle management
Be well versed in all stages of pharmaceutical development and understand the global regulatory trends for CMC activities, to proactively shape strategies and ensure robust and high-quality regulatory filings in all countries active
Benchmark against external leaders and best in class practices to drive superior performance of products, processes and people
Maintain an active understanding of the future trends of medicine to build an organization adaptable for the future
Inspire, engage and develop team members, promote an inclusive, psychologically safe, and high performing culture aligned with Takeda values
Builds future leadership by mentoring direct reports and emerging talent, identifying and addressing development needs, and ensuring a strong succession pipeline for critical roles
Qualification
Required
PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 15+ years relevant industry experience
10+ years of direct industry experience in relevant development and manufacturing functional area of expertise
Demonstrated people and program management skills, critical thinking, the ability to think outside the box, and situational leadership skills
Demonstrated ability to anticipate potential issues and proactively manage a team to implement solutions
Experience in ensuring the implementation of necessary quality processes and standards to facilitate a smooth transition from product development to commercialization
Experience in writing regulatory documents and guidelines
Comprehensive understanding of the global organization's structure, functions, and methods, as well as its overall R&D operations
Excellent organizational and communication skills including the ability to influence at all levels of the organization and manage projects across businesses and globally
Demonstrated ability to make difficult decisions, negotiate challenging issues, and arrive at mutually beneficial solutions
Ability to analyze a wide range of information and data to make informed management decisions regarding potential risks associated with product quality and regulatory compliance
Demonstrated talent management skills, effectively lead, and motivate a team of direct reports, leveraging their strengths and identifying areas for improvement
Proven record of building mutually respectful relationships across global regions and companies to foster communication and achieve strategic goals
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
Operational experience in pharmaceutical drug development with significant direct exposure to clinical development
Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams
A strong understanding of healthcare business practices and a comprehensive knowledge of the pharmaceutical industry
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
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 (34)
2024 (40)
2023 (39)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Recent News
2025-12-30
Company data provided by crunchbase