Senior Process Scientist (gRNA Process Development)

Location: Anywhere in Europe, with hybrid and remote work options

Salary: Minimum €59,000 annually when the role is located in Italy; salary, bonus, and benefits vary according to the local market in other countries.

Company

hirify.global is an international research-focused biopharmaceutical group developing and commercializing innovative medicines, including treatments and patient support services for rare and ultra-rare diseases.

What you will do

• Lead process development, manufacturing, and control strategies for synthetic nucleotides and assigned gRNA-based projects.
• Design and oversee gRNA development workstreams, including technology transfer to manufacturing.
• Manage CRO and CDMO activities, including partner selection, qualification, technical governance, performance monitoring, and budget oversight.
• Lead troubleshooting, risk management, root-cause investigations, and deviation assessments.
• Support gene therapy programs from candidate selection through clinical development, commercial launch, and lifecycle management.
• Prepare, review, and approve development protocols, reports, stability studies, batch records, SOPs, and CMC regulatory documentation.

Requirements

• MSc or higher in biotechnology, bioengineering, biology, biochemistry, chemistry, chemical engineering, or a related field.
• 5–10 years of relevant industrial experience in biotechnology or pharmaceuticals, including gene editing, CGT/ATMPs, and nucleic acid-based product development.
• Strong expertise in gRNA process development, scale-up, GMP manufacturing technology transfer, and process validation.
• Knowledge of solid-phase oligo synthesis, enzymatic synthesis, chemoenzymatic ligation, CQAs, QbD, DoE, CPP/CQA identification, control strategies, and risk assessment.
• Experience overseeing outsourced development through CROs/CDMOs, including troubleshooting, escalation management, and data-driven performance monitoring.
• Understanding of GMP, regulatory requirements, the CMC development lifecycle, technical writing, regulatory documentation, cross-functional collaboration, and stakeholder management.

Culture & Benefits

• Work within an international, matrixed research and development environment.
• Flexible working arrangements with remote and hybrid options across Europe.
• Annual performance-based bonus eligibility.
• Benefits may include pension, private medical insurance, wellbeing and flexible benefits programmes, healthcare support, work-life balance initiatives, relocation support, and tax assistance for foreign colleagues.
• Access to training, development resources, and knowledge-sharing opportunities.