Head of Downstream BioProcess Development

Takeda•Lexington, MA

12d•Hybrid

About The Position

You will lead the Biotherapeutics Downstream Process Development function, directing a multidisciplinary team of scientists and engineers who develop and characterize purification processes for biotherapeutics across early- and late-stage assets. You will oversee internal development work and external partners, including contract development and manufacturing organizations, to ensure project deliverables, timelines, and quality expectations are met. You will manage preparation and approval of CMC sections for global regulatory submissions and lead responses to regulatory questions. You will drive rapid, phase-appropriate early-stage development toward Investigational New Drug (IND) applications using platform strategies, maintain a strong external presence to bring scientific advances and efficiency into the organization, and contribute to Pharmaceutical Sciences-wide initiatives that shape development strategy and long-term technical priorities.

Requirements

Ten or more years of industry experience in biologics downstream process development with progressive leadership responsibility; advanced degree in biochemical engineering, chemical engineering, biochemistry, chemistry, or a related discipline required; doctoral degree preferred.
Demonstrated experience collaborating with partner organizations to streamline development activities and shorten time to market.
Demonstrated experience preparing and approving chemistry, manufacturing, and controls sections for global regulatory submissions and responding to regulatory agency queries.
Proven track record managing external development and manufacturing partners, including contract development and manufacturing organizations, and overseeing technology transfer and scale-up.
Deep technical expertise in downstream purification platform technologies, including chromatography and filtration, process characterization, viral clearance strategy, and product quality attributes.
Experience driving early-stage development to IND applications using phase-appropriate, platform-based approaches and risk-based development strategies.
Experience serving on process development or biotherapeutics leadership teams and contributing to organization-wide Pharmaceutical Sciences initiatives that enable standardization and capability growth.
Strong leadership skills with experience building, mentoring, and retaining high-performing, diverse teams and influencing cross-functional partners and senior leadership.
Established external scientific presence and professional network used to source new approaches, collaborations, and efficiency gains.
Working knowledge of Good Manufacturing Practices, quality systems, process validation, and regulatory requirements for clinical and commercial biologics manufacturing.
Experience using AI-enabled tools (for example, for experiment planning, data analysis, or knowledge search) alongside automation and digital tools to improve process consistency and reproducibility.
Clear written and verbal communication skills with experience drafting technical sections of regulatory filings and presenting technical strategy to senior leadership and external audiences.

Responsibilities

Lead and develop a multidisciplinary team responsible for purification process development and characterization for monoclonal antibodies, fusion proteins, and related biologic modalities across discovery, preclinical, clinical, and commercial phases.
Serve on the biotherapeutics process development leadership team to set technical strategy, coordinate priorities across programs, and support decisions that advance the portfolio.
Work closely with upstream, analytical, and drug product development organizations to align activities, reduce handoffs, and streamline process development to accelerate time to market.
Contribute to Pharmaceutical Sciences-wide initiatives, collaborating with peers across development, manufacturing, quality, and regulatory groups to drive standardization, platform improvements, and capability building.
Oversee downstream development activities conducted internally and at contract development and manufacturing organizations to ensure project deliverables, timelines, and transfer readiness.
Manage preparation, review, and approval of chemistry, manufacturing, and controls sections for global regulatory submissions and coordinate timely responses to agency questions.
Drive rapid, phase-appropriate development to Investigational New Drug applications using platform process strategies and risk-based decision making.
Lead technology transfer, scale-up, process characterization, and validation efforts to enable reliable manufacture at scale.
Ensure adherence to Good Manufacturing Practices and quality systems across internal teams and external partners.
Cultivate and leverage external scientific and industry networks, partnerships, and vendors to introduce new approaches, efficiencies, and best practices.
Mentor and develop leaders and scientists within the team and influence partners and senior leadership on downstream strategy.