Director, Bioprocess / Process Development Pivotal Drug Substance

Location: Cambridge, Massachusetts and/or Thousand Oaks, California, United States

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead a multisite drug substance organization integrating cell culture and purification disciplines.
• Direct development, characterization, scale-up, lifecycle management, and control strategy development for biologics processes.
• Manage and develop an organization of more than 30 scientists and engineers, including portfolio prioritization and resource allocation.
• Partner with engineering, manufacturing, and external collaborators to support process transfer and commercialization.
• Author and review global regulatory filings and respond to regulatory agency questions.
• Drive innovative bioprocess technologies, automation, digital strategies, publications, patents, and external scientific engagement.

Requirements

• Doctorate degree with 4 years of scientific process development experience, or master's degree with 8 years, or bachelor's degree with 10 years.
• At least 4 years of people management or leadership experience directing teams, projects, programs, or resource allocation.
• Experience in biopharmaceutical process development, including cell culture bioreactor processes or downstream purification.
• Strong understanding of late-stage biologics development, process design, characterization, validation, and regulatory interactions.
• Ability to provide scientific and engineering leadership on complex cross-functional programs and communicate at senior levels.

Nice to have

• PhD in biochemistry, biochemical engineering, chemical engineering, or a related discipline.
• 10 or more years of biopharmaceutical process development experience.
• Experience with statistical data analysis, technical decision-making, talent development, publications, patents, and industry forums.

Culture & Benefits

• Collaborative, innovative, science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off plans and career development opportunities.
• Flexible work models where applicable to the work location.