Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)

Location: On-site in Cambridge, Massachusetts or Thousand Oaks, California, United States. The role may require approximately 10–20% domestic and international travel.

Company

hirify.global is a biotechnology company that researches, manufactures, and delivers medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead a global, multisite organization of more than 30 scientists and engineers within Drug Substance Technologies Synthetics.
• Direct the development, characterization, technology transfer, validation, commercialization, and lifecycle management of synthetic and hybrid drug substance manufacturing processes.
• Set technical and strategic priorities across early- and late-phase clinical and commercial portfolios.
• Build engineering and technology platforms, strengthen technical capabilities, and deploy innovative approaches that improve robustness, reduce cost, and shorten development timelines.
• Manage portfolio prioritization, resource allocation, budgets, talent development, succession planning, and organizational performance.
• Partner with manufacturing sites, CDMOs, and cross-functional teams on process transfer, clinical and commercial supply, regulatory filings, and responses to agency questions.

Requirements

• Doctorate degree plus 5 years of scientific process development experience, or master’s degree plus 9 years, or bachelor’s degree plus 11 years.
• At least 5 years of direct people management or organizational leadership experience.
• Expertise in synthetic or hybrid pharmaceutical process development, including process design, optimization, characterization, validation, and scale-up.
• Experience with cGMP operations, technology transfer, commercialization of active pharmaceutical ingredients, and manufacturing through CMOs or CDMOs.
• Experience preparing regulatory filings, annual product reviews, briefing documents, and responses to regulatory questions.
• Ability to work on-site in Cambridge, MA or Thousand Oaks, CA, with approximately 10–20% domestic and international travel.

Nice to have

• PhD in Chemical Engineering or a related discipline.
• 10+ years of synthetic or hybrid pharmaceutical process development experience.
• Experience managing an organization of more than 20 staff members.
• Subject matter expertise in small molecules, peptides, oligonucleotides, or bioconjugates.
• Active scientific engagement through publications, patents, and industry forums.

Culture & Benefits

• Collaborative, innovative, science-based environment focused on patient impact.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus, stock-based long-term incentives, and award-winning time-off plans.
• Career development opportunities and flexible work models where applicable.