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Head of Characterization Small Molecules

Takeda

Boston, MA; Cambridge, MAHybridPosted 54 days ago$212,000.00 - $333,190.00
Full TimeDirector & AboveResearch & ScientistPharmaceutical
Original posting ↗

Summary

Technical/Functional (Line) Expertise: Deep expertise in mass spectrometry (MS), nuclear magnetic resonance (NMR), and advanced microscopy applied to drug discovery, development, and manufacturing. Ability to generate in-depth understanding of molecular attributes, structure, stability, and quality for small and/or large molecules across the CMC lifecycle. Oversight of advanced bioassay platforms to support product characterization and performance understanding. Strong grounding in analytical characterization within pharmaceutical CMC, including support of development, scale-up, and manufacturing. Capability to evaluate, implement, and scale emerging analytical technologies to strengthen characterization depth and efficiency. Experience with crystallography, particle science, and physical chemistry applied to pharmaceutical products. Hands-on experience implementing modelling, digital tools, and advanced data analytics in characterization workflows. Experience managing external analytical partners and supporting transfer of methods to manufacturing environments. Technical experience supporting regulatory submissions and approval processes from an analytical characterization perspective.

Job description

Objectives/Purpose

  • Establish a clear vision and roadmap for extended characterization that aligns with discovery, development, and manufacturing needs across small and mid molecules (Oligo, small molecules and peptides).
  • Implement, optimize, and apply cutting-edge techniques (e.g., MS, NMR, microscopy) to strengthen understanding of drug substance and product properties, stability, and quality.
  • Identify and integrate emerging technologies and digital tools to modernize characterization platforms and improve efficiency and scientific impact.
  • Create and sustain a high-performing team through hiring, mentoring, resource planning, and talent development.
  • Partner with analytical, DS/DP, manufacturing, and quality teams to ensure characterization insights are embedded into development and production decisions.
  • Build external collaborations and enhance scientific reputation through publications, conferences, and industry engagement.

Accountabilities

  • Define, lead, and deliver the extended characterization strategy across the CMC portfolio to support drug discovery, development, and manufacturing.
  • Oversee the implementation, optimization, and application of advanced analytical platforms (e.g., MS, NMR, microscopy, bioassays) to enable deep process and product understanding.
  • Identify, evaluate, and integrate emerging analytical and digital technologies to modernize characterization capabilities and improve efficiency and scientific impact.
  • Build, mentor, and lead a high-performing scientific organization, including talent development, succession planning, budgeting, and resource allocation.
  • Partner with analytical, DS, DP, manufacturing, and quality teams to ensure characterization insights are embedded into development, scale-up, and production decisions.
  • Establish and manage strategic external partnerships and enhance organizational reputation through publications, conferences, and thought leadership.

Core Elements Related to This Role

  • Set enterprise strategy for extended characterization across the CMC portfolio
  • Enable deep product and process understanding using advanced analytical technologies
  • Build and sustain best-in-class analytical capability through talent, platforms, and innovation
  • Embed characterization insights into development and manufacturing decisions

Dimensions and Aspects

Technical/Functional (Line) Expertise: Deep expertise in mass spectrometry (MS), nuclear magnetic resonance (NMR), and advanced microscopy applied to drug discovery, development, and manufacturing. Ability to generate in-depth understanding of molecular attributes, structure, stability, and quality for small and/or large molecules across the CMC lifecycle. Oversight of advanced bioassay platforms to support product characterization and performance understanding. Strong grounding in analytical characterization within pharmaceutical CMC, including support of development, scale-up, and manufacturing. Capability to evaluate, implement, and scale emerging analytical technologies to strengthen characterization depth and efficiency. Experience with crystallography, particle science, and physical chemistry applied to pharmaceutical products. Hands-on experience implementing modelling, digital tools, and advanced data analytics in characterization workflows. Experience managing external analytical partners and supporting transfer of methods to manufacturing environments. Technical experience supporting regulatory submissions and approval processes from an analytical characterization perspective.

Leadership: Strategic and scientific leadership: Set direction for extended characterization and provide credible thought leadership in advanced analytical science. People and capability building: Build, mentor, and sustain a high-performing, future-ready scientific organization. Cross-functional influence: Align and partner effectively across CMC, DS, DP, manufacturing, and quality to drive impact. Change and innovation leadership: Lead modernization of analytical platforms and adoption of emerging technologies.

Decision-making and Autonomy: Full authority to define and drive the extended characterization vision, priorities, and roadmap across the CMC portfolio. Autonomy to select, implement, and evolve advanced analytical technologies and digital tools. Decision rights over team structure, hiring, talent development, budgeting, and resource prioritization. Authority to establish external collaborations and set the depth and direction of characterization that informs development and manufacturing decisions.

Interaction: Work closely with ADQC, DS, DP, manufacturing, and quality teams to align characterization efforts with development and production needs. Provide direction, coaching, and prioritization to internal scientific teams to ensure delivery and capability growth. Engage with senior scientific and functional leaders to shape priorities, strategy, and investment decisions through analytical insight. Build strategic relationships with external partners and represent the organization through publications and scientific forums.

Innovation: Modernize and evolve characterization platforms to maintain cutting-edge analytical depth and efficiency. Adopt emerging and digital and modelling technologies to enhance data quality, insight generation, and decision-making. Leverage external innovation through academic and industry partnerships to accelerate scientific advancement.

Complexity: Enterprise and portfolio complexity: Oversight of extended characterization across diverse programs spanning discovery, development, and manufacturing. High scientific and technical complexity: Integration of multiple advanced analytical platforms applied to varied molecules and modalities. Cross-functional and stakeholder complexity: Managing interdependencies across analytical, DS, DP, manufacturing, quality, and external partners. Change and regulatory complexity: Driving innovation and modernization within a highly regulated, risk-sensitive environment.

Education, Behavioural Competencies and Skills

  • Ph.D. with 5-7+ years, MSc with 10-13+ years, BSc with 12-15+ years of industry experience in a relevant life sciences discipline with in analytical development and characterization.
  • Deep experience with advanced characterization techniques (e.g., MS, NMR, microscopy) applied within CMC.
  • Strong understanding of analytical development supporting discovery, development, manufacturing, and regulatory submissions.
  • Proven scientific leadership, strong communication and collaboration skills, and ability to manage complex priorities and stakeholders.
  • Experience supporting regulatory submissions and approval processes.
  • Track record in modernizing analytical platforms or introducing new technologies at scale.
  • Leadership: Proven track record of leading teams, developing talent, and driving strategic initiatives.
  • Strategic thinking: analyses current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focused on priorities.
  • Results oriented: Demonstrated ability to drive initiatives from concept to execution.
  • Structured, goal-oriented and highly motivated.
  • Fluent in English. Japanese is a plus.
  • Strong and proven ability to work transversally on a local and global level.

Requirements

  • Ph.D. with 5-7+ years, MSc with 10-13+ years, BSc with 12-15+ years of industry experience in a relevant life sciences discipline with in analytical development and characterization.
  • Deep experience with advanced characterization techniques (e.g., MS, NMR, microscopy) applied within CMC.
  • Strong understanding of analytical development supporting discovery, development, manufacturing, and regulatory submissions.
  • Proven scientific leadership, strong communication and collaboration skills, and ability to manage complex priorities and stakeholders.
  • Experience supporting regulatory submissions and approval processes.
  • Track record in modernizing analytical platforms or introducing new technologies at scale.
  • Proven track record of leading teams, developing talent, and driving strategic initiatives.
  • Strategic thinking: analyses current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focused on priorities.
  • Results oriented: Demonstrated ability to drive initiatives from concept to execution.
  • Structured, goal-oriented and highly motivated.
  • Fluent in English. Japanese is a plus.
  • Strong and proven ability to work transversally on a local and global level.

Benefits

  • 401(k) Matching
  • Medical, Dental & Vision
  • Unlimited PTO

Company overview

Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.

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