Senior Upstream Process Scientist – Biosimilar Focus

Rezon Bio; Warszawa; On-site; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Private medical care

Life insurance

Pension program and retirement support

One additional paid day off per year

Flex Benefits budget

Free transportation to workplace

On-site cafeteria with live cooking

Weekly fruit and vegetable days

Access to psychological support

Job summary

Rezon Bio is seeking an Expert in Upstream Process Development (USP) to lead development, optimization, and characterization of upstream processes for biologics. The role involves working with cell cultures, bioreactors, and advanced analytics, plus regulatory support and tech transfer.

The candidate will mentor staff, collaborate across teams, and contribute to CMC packages while ensuring cGMP compliance and robust data-driven decision making.

Qualifications

• Minimum 5 years in the pharmaceutical/biotech industry.
• Expertise in USP process development and bioreactor work across scales.
• Experience with biosimilar development: CMC packages, EMA/FDA/MHRA interactions, technology transfer.
• Knowledge of regulatory, clinical, and IP requirements in biosimilar development.
• Proficiency in data analysis and DoE.

Responsibilities

• Lead USP projects from early development through tech transfer.
• Supervise lab-scale studies and operate bioreactors (15 mL–50 L).
• Design experiments (DoE) and analyze data (JMP, models).
• Support CMC and regulatory documentation (BLA/MAA).
• Act as USP SME during regulatory interactions and due diligence.
• Collaborate across DSP, analytical, regulatory, and clinical teams.
• Mentor junior staff and support team capability development.
• Participate in tech transfer and cGMP activities.
• Present results and contribute to project reviews.

Skills

USP process development

Bioreactors handling

Data analysis (JMP)

Experimental design (DoE)

Regulatory collaboration

MS Office / MS Project

English communication

Education

Higher education in biotech/chemistry/pharmacy

Tools

JMP

DoE software

Job description

Rezon Bio is seeking an Expert in Upstream Process Development (USP) to lead development, optimization, and characterization of upstream processes for biologics. The role involves working with cell cultures, bioreactors, and advanced analytics, plus regulatory support and tech transfer.

The candidate will mentor staff, collaborate across teams, and contribute to CMC packages while ensuring cGMP compliance and robust data-driven decision making.