Head, Biotherapeutics Process Development (BPD)

Responsibilities

• Set the vision, strategy and direction for the global Biotherapeutics Process Development (BPD) organization, spanning early preclinical development through commercialization and licensure of product candidates for developability assessments, cell line development, process development (Upstream and downstream), process technology transfer and support of clinical manufacturing of drug substance (DS) using mammalian cell or related expressions systems.
• Own the bioprocess development strategy for all biotherapeutic modalities (e.g., mAbs, bispecifics, fusion proteins, ADCs, novel biologics), ensuring robust, scalable, and cost-effective processes.
• Lead a high-performing, diverse global organization, including multiple sites and functional teams, fostering a culture of scientific excellence, patient focus, collaboration, continuous improvement, and innovation.
• Foster a customer-focused culture of high performance, out-of-the-box thinking, innovation and learning, empowerment, diversity, inclusion and trust.
• Champion talent development, organizational capability building, succession planning, and training including external scientific engagement (conferences, consortia, publications, and industry networks).
• Drive adoption and implementation of innovative and digital technologies (e.g., intensified/continuous processing, high-throughput screening, automation, digital/AI tools, PAT) to increase speed, quality, robustness, and productivity across BPD.

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.
• Build future leadership by mentoring direct reports and emerging talent, identifying and addressing development needs, and ensuring a strong succession pipeline for critical roles.

Qualifications

• 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‚Äôs 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 track 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