Process Development Senior Scientist (Biologics)

Location: Framingham, United States; 5-day on-site expectation

Salary: $146,000–$189,000 base pay per year, plus performance incentive bonus and equity eligibility.

Company

hirify.global is a biotechnology company developing oncolytic immunotherapies based on its proprietary RPx platform to transform cancer treatment.

What you will do

• Lead late-stage drug product process and product characterization studies supporting PPQ, BLA submissions, and commercial readiness.
• Develop stable frozen liquid and lyophilized formulations for hirify.global products.
• Provide technical expertise for GMP drug product manufacturing, process optimization, validation, change controls, deviations, and CAPAs.
• Drive continuous improvement through technological innovation and alternative process technologies.
• Author protocols, reports, risk assessments, SOPs, batch records, and regulatory filing sections.
• Represent process development during internal and external audits and contribute to cross-functional production-readiness initiatives.

Requirements

• Bachelor’s degree in a relevant field; an advanced degree is preferred.
• At least 2 years of experience in biologics drug product process development.
• Experience with frozen liquid and lyophilized drug product formulation development.
• Experience with technologies or assays for measuring sub-visible and sub-micron particle size and concentration, such as NanoSight or FlowCam.
• Strong organizational, communication, collaboration, and attention-to-detail skills.
• Ability to work on-site in Framingham five days per week.

Culture & Benefits

• Collaborative, bold, dedicated, and candid working culture.
• Medical, dental, and vision insurance.
• 401(k) matching and flexible time off.
• Paid holidays, including a year-end shutdown.
• Annual performance incentive bonus and performance-based equity opportunities.
• Some domestic and international travel may be required.