Head, Biotherapeutics Process Development; BPD

Job Description

Objectives:

• 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 develop ability 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.

How will you contribute:

• 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
  and maintain
  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.

Dimensions and Aspects:

Technical/Functional (Line) Expertise

• 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.

Leadership

• 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…