Upstream Biological Process Lead Scientist (Biotech)

TL;DR

Upstream Biological Process Lead Scientist (Biotech): Driving the industrialization and lifecycle management of upstream biopharmaceutical processes with an accent on technology transfer, scale-up, and validation. Focus on leading process insourcing, ensuring GMP compliance, and coordinating cross-functional activities across R&D, Production, and Quality.

Location: Must be based in or be able to relocate to Parma, Italy

Salary: From €62,000

Company

hirify.global is an international research-focused biopharmaceutical group and certified B Corp dedicated to sustainable innovation and promoting a healthier world.

What you will do

• Lead process insourcing, technology transfer, scale-up, and validation activities for upstream biopharmaceutical processes.
• Coordinate process development and optimization with internal R&D teams and external CDMO partners.
• Apply Quality by Design (QbD) principles to ensure robust, scalable, and compliant manufacturing.
• Support regulatory submissions (MAA, NDA, BLA) and represent CMC process topics to health authorities.
• Manage product lifecycle activities, including process characterization, risk assessments, and continuous improvement.
• Provide technical expertise for investigations, deviations, and CAPAs to ensure supply reliability.

Requirements

• MSc or PhD in Biotechnology, Biochemical Engineering, or related discipline.
• At least 10 years of experience in biopharmaceutical drug substance process development.
• Proven leadership in complex biologics CMC programs and CDMO management.
• Deep expertise in upstream manufacturing, including mammalian cell culture (CHO) and single-use bioreactors.
• Solid knowledge of GMP requirements and global regulatory frameworks (FDA, EMA, ICH).
• Good knowledge of English (written and spoken).

Culture & Benefits

• Comprehensive benefits package including pension and private medical insurance.
• Annual bonus scheme based on company and individual performance.
• Flexible working arrangements and remote work options.
• Robust relocation support for foreign colleagues.
• Access to continuous training and professional development resources.