Head, Biotherapeutics Process Development (BPD)

Role Summary

Head, Biotherapeutics Process Development (BPD) leads the global Biotherapeutics Process Development organization, spanning early preclinical development through commercialization. The role sets vision and strategy for end-to-end bioprocess development, oversees multiple sites and teams, and drives adoption of innovative and digital technologies to enhance speed, quality, robustness and productivity. It requires inspiring leadership, collaboration with cross-functional partners, and a strong focus on talent development and organizational capability building.

Location

Boston, MA

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 with Analytical Development, Drug Product Development, Manufacturing, Quality and Regulatory to ensure clinical products are manufactured with high quality and to drive continuous, phase-appropriate process optimization.
• Establish, maintain and govern global standards, policies, and best practices in biotherapeutic process development, including data integrity, knowledge management, and governance.
• Manage budgets, resources, and capacity, aligning investment and headcount with portfolio priorities, and oversee 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 forums.
• Ensure successful technology transfer and late-stage process characterization, validation, and control strategy definition to support regulatory submissions and lifecycle management.
• Be well versed in all stages of pharmaceutical development and understand global regulatory trends for CMC activities to shape strategies for robust regulatory filings.
• Benchmark against external leaders to drive superior performance of products, processes and people.
• Maintain an understanding of future medicine trends to build an adaptable organization; mentor and develop team members and ensure succession planning.

Qualifications

• PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 15+ years of relevant industry experience
• 10+ years of direct industry experience in relevant development and manufacturing functional areas
• Proven people and program management skills, critical thinking, creativity, and situational leadership
• Ability to anticipate potential issues and proactively manage a team to implement solutions
• Experience implementing quality processes and standards to facilitate transition from product development to commercialization
• Experience in writing regulatory documents and guidelines
• Strong understanding of global R&D operations and organizational structure
• Excellent organizational and communication skills; ability to influence at all levels and manage global projects
• Proven ability to lead, motivate, and develop large, multi-disciplinary teams; strong stakeholder management
• Ability to analyze information to assess risks related to product quality and regulatory compliance
• Track record of driving business process transformation and organizational culture change

Skills

• End-to-end bioprocess development for biologics (cell line development, upstream, downstream, process characterization, validation)
• Global regulatory knowledge related to CMC, process development, and biologics manufacturing
• Strategic leadership, cross-functional collaboration, and executive presence
• Data governance, data integrity, and knowledge management
• Technology transfer, process validation, and lifecycle management
• Innovation and digital technologies adoption (e.g., intensified processing, high-throughput screening, automation, AI/tools, PAT)

Education

• PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science

Additional Requirements

• Operational experience in pharmaceutical drug development with exposure to clinical development
• Global leadership experience with diverse, geographically dispersed teams
• Ability to navigate a complex global ecosystem and drive change across functions and regions