Upstream Biological Process, Lead Scientist

Location: Parma, Italy

Salary: Minimum €62,000 annually, plus an annual performance bonus and benefits.

Company

hirify.global is an international research-focused biopharmaceutical group operating in more than 30 countries, with global manufacturing and supply operations across pharmaceutical production sites and external partners.

What you will do

• Lead the industrialization, insourcing, technology transfer, scale-up, and validation of upstream biopharmaceutical processes.
• Coordinate upstream process development, optimization, characterization, and lifecycle management with R&D teams and external CMOs/CDMOs.
• Design, execute, and evaluate pilot-scale studies supporting process development, scale-up, and technology transfer.
• Apply Quality by Design principles to process characterization, control strategies, validation plans, and risk mitigation.
• Support regulatory submissions and represent CMC process topics in interactions with health authorities.
• Collaborate with Production, Quality, Engineering, and Maintenance on feasibility studies, equipment qualification, GMP documentation, investigations, deviations, change controls, CAPAs, and manufacturing training.

Requirements

• MSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry, or a related discipline.
• At least 10 years of experience in biopharmaceutical drug substance process development and complex biologics CMC programs.
• Deep expertise in upstream process development and manufacturing, including mammalian cell culture, preferably CHO, single-use bioreactors, centrifugation, and depth filtration.
• Experience with process optimization, scale-up/down, technology transfer, industrialization, lifecycle management, and commercialization of biologics.
• Knowledge of GMP and global regulatory frameworks, including FDA, EMA, ICH, and CMC guidelines, with experience supporting submissions and working with approved facilities.
• Good written and spoken English, strong analytical and communication skills, and willingness to travel when necessary.

Culture & Benefits

• Research-focused environment centered on sustainable innovation, reliability, transparency, and ethical behavior.
• Comprehensive benefits package including pension, private medical insurance, wellbeing programs, and flexible benefits.
• Annual performance bonus subject to company and individual performance.
• Development resources, training, work-life balance initiatives, flexible working arrangements, remote work options, and tax assistance for foreign colleagues.
• Relocation support is available.