Senior Process Scientist (Biotech)

TL;DR

Senior Process Scientist (Biotech): Leading process development and manufacturing oversight for RNA-based gene editing components with an accent on CMC strategy, technology transfer, and CDMO management. Focus on advancing in vivo LNP programs from candidate selection through clinical development and commercial launch.

Location: Must be based in Europe (Remote or Hybrid options available).

Salary: From €59,000 (based on Italian framework, subject to local market adjustment).

Company

hirify.global is an international research-focused biopharmaceutical group and a certified B Corp dedicated to developing innovative treatments for rare and ultra-rare disorders.

What you will do

• Define and lead development plans for synthetic nucleotide manufacturing and control strategies.
• Design and oversee gRNA development workstreams and technology transfers to GMP manufacturing.
• Manage outsourced development activities, including CRO/CDMO selection, auditing, and technical oversight.
• Lead root cause investigations, deviation assessments, and proactive risk management.
• Review and approve technical documentation, including protocols, reports, and regulatory sections (IND, IMPD, IB).
• Support business development evaluations and contribute to departmental strategic goals.

Requirements

• MSc in biotechnology, bioengineering, biology, biochemistry, chemistry, or chemical engineering.
• 5-10 years of industrial experience in biotech/pharma with exposure to gene editing, CGT/ATMPs, and nucleic acid products.
• Proven expertise in process development, scale-up, technology transfer, and process validation for gRNA-based products.
• Solid understanding of GMP, regulatory requirements, and CMC development lifecycle.
• Experience managing outsourced development activities (CROs/CDMOs) with strong technical governance.
• Ability to operate effectively in a matrix organization and influence cross-functional teams.

Culture & Benefits

• Comprehensive healthcare programs and private medical insurance.
• Flexible working arrangements and remote work options.
• Annual bonus scheme based on company and individual performance.
• Pension and wellbeing programs.
• Robust relocation support and tax assistance services for foreign colleagues.