Process Development Scientist (Biotechnology)

Location: Cambridge, Massachusetts, United States; may telecommute.

Annual salary: $111,685–$144,605, plus stock, retirement, medical, life and disability insurance, and eligibility for an annual bonus.

Company

hirify.global develops and commercializes medicines and manages pharmaceutical product and process lifecycles.

What you will do

• Provide technical input to drug product commercialization and synthetic process development programs.
• Design, execute, and document characterization studies for products, processes, equipment, production scales, and raw material changes.
• Support process scale-up, technology transfers, process introduction, and lifecycle management for clinical and commercial products.
• Author process transfer documents, technical reports, process performance qualification reports, and regulatory submission sections.
• Apply scientific, engineering, statistical, and biophysical principles to nonconformance investigations and corrective/preventive actions.
• Collaborate with engineering, analytical, quality, regulatory, clinical, and commercial manufacturing functions.

Requirements

• Master’s degree or foreign equivalent in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related field.
• At least 2 years of experience in the offered position or a related Scientist role.
• Experience with statistical evaluations, process capability, data simulations, and engineering-based bench- and pilot-scale models.
• Experience with process scale-up and technology transfer, including gap analysis, root cause analysis, and risk assessment.
• Experience designing process validation and sampling plans, monitoring continued process validation, triaging excursions, and developing remediation plans.
• Chemistry and biology laboratory skills, including weighing, dispensing, pipetting, aseptic handling, and bench-scale fill-finish operations in a biosafety cabinet.

Culture & Benefits

• Work across cross-functional product development and manufacturing teams.
• Support both pipeline and commercial product portfolios throughout the commercialization lifecycle.
• Stock and retirement benefits.
• Medical, life, and disability insurance.
• Annual bonus eligibility.