Head, Biotherapeutics Process Development (BPD)

Takeda•Boston, MA

About The Position

As a member of the Pharmaceutical Sciences Leadership Team (PSLT) 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 a doption 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.

Requirements

Extensive, end to end understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.)
Deep expertise in bioprocess development for biologics (e.g., cell line development, upstream processing, downstream purification, process characterization, and validation.
Strong understanding of the global regulatory environment and evolving expectations relation to CMC, process development, and manufacturing of biologics.
Demonstrated ability to translate scientific and technical advances into practical, scalable, and compliant manufacturing solutions.
Demonstrated ability to work across functions, regions and cultures
Enterprise level leadership with the ability to set a compelling vision, inspire, motivate and drive results
Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
Proven skills as an effective team player who can engender credibility and confidence within and outside the company
Ability to distil complex issues and ideas down to simple comprehensible terms.
Demonstrate strong executive leadership presence and confidence, consistently showing sound judgement, poise, and credibility,
Embraces and demonstrates a diversity and inclusion mindset and role models inclusive leadership behaviors for the organization
Ability to develop and execute a global workforce and talent strategy for all colleagues in the global, regional and local BPD organizations.
Ability to make highly complex decisions that impact the enterprise.
Accountable for decision making for designated function.
Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions.
Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution.
Accountable for designing and implementing vision and strategy for designated scope
Navigate the evolving external and internal environment effectively, leading others through change by creating, inspiring, and engaging the workplace.
Implement R&D’s partnership strategy effectively.
Represent Takeda in high-level negotiations, resolving conflicts constructively.
Build strong partnerships and drive role clarity with other interfacing Takeda functions.
A visionary and forward-thinking leader with the ability to influence and effectively drive organizational change, continuous improvement, and innovation in bioprocess development.
Comfortable in constructively challenging the status quo and presenting innovative solutions.
The ability to take risks thoughtfully, implement innovative solutions, and accelerate time to market.
Ability to work effectively in a complex global ecosystem, encompassing both internal and external factors.
Comprehensive understanding of therapeutic areas, indications, and modalities.
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.

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 a nd 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.

Benefits

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.

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