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

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

Salary: $202,943.45–$274,570.55 annually.

Company

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

What you will do

• Lead a global, multi-site organization of more than 30 scientists and engineers, including talent development, succession planning, performance management, and resource allocation.
• Direct strategic development, characterization, validation, technology transfer, and lifecycle management for synthetic and hybrid drug substance manufacturing processes.
• Establish engineering platforms and improve process robustness, development speed, cost effectiveness, and operational excellence.
• Partner with manufacturing teams, external collaborators, and CDMOs on technology transfer, validation, and clinical or commercial supply.
• Author and review regulatory filings, briefing documents, annual product reviews, and responses to regulatory questions.
• Represent the Drug Substance Technologies – Synthetics organization in leadership, cross-functional, scientific, and external industry forums.

Requirements

• Doctorate degree and 5 years of scientific process development experience; or master’s degree and 9 years; or bachelor’s degree and 11 years.
• At least 5 years of direct people management or organizational leadership experience.
• Experience in synthetic or hybrid pharmaceutical process development, including process design, optimization, characterization, validation, and commercialization.
• Expertise in cGMP operations, technology transfer, scale-up, active pharmaceutical ingredients, and quality risk management.
• Working knowledge of applicable regulatory and ICH guidance, with experience drafting IND or MAA filings and regulatory responses.
• Proven scientific and engineering leadership on complex cross-functional programs, including statistical analysis, technical decision-making, and quality by design.

Nice to have

• PhD in Chemical Engineering or a related discipline.
• 10+ years of synthetic or hybrid pharmaceutical process development experience.
• Experience managing organizations of more than 20 staff members and working with contract manufacturing organizations.
• Subject matter expertise in small molecule, peptide, oligonucleotide, or bioconjugate process development.
• Active scientific engagement through publications, patents, conferences, and industry forums.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible staff and dependents.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and a discretionary annual bonus.
• Paid time-off programs, work-life balance support, and career development opportunities.
• Inclusive workplace with reasonable accommodations available during hiring and employment.