USP Development Specialist (f/m/d) (Gdańsk)

We are seeking a motivated and skilled USP Development Specialist to join our Process Development team. In this role, you will be responsible for designing and executing laboratory experiments, supporting bioprocess development activities, and ensuring the highest standards of laboratory work and documentation. This position offers an exciting opportunity to contribute to the development of cutting-edge biopharmaceutical products in a collaborative and innovative environment.

Your responsibilities

• Perform general laboratory tasks, including solution preparation, cell passaging, calibration, and maintenance of laboratory equipment.
• Operate and manage bioreactor cultures of various scales (e.g., 15 mL, 250 mL, 3 L, 10 L, 50 L).
• Independently design, prepare, and conduct laboratory experiments.
• Document all activities in accordance with applicable procedures and standards.
• Prepare protocols, reports, standard operating procedures (SOPs), and other laboratory-related documentation. Independently compile comprehensive reports from large experimental data sets (e.g., process characterization, small-scale model qualification, process development summary reports), including data analysis (for regulatory submission purposes).
• Manage laboratory inventory, including reagents and consumables.
• Support data collection from recorders and ensure the integrity of data generated by the laboratory.
• Contribute to the implementation of the quality system within the bioprocess development group in cooperation with other team members.
• Advanced use of statistical analysis software (e.g., JMP or equivalent): complex DoE experiments, predictive modeling, etc.
• Supervise and coordinate large experimental packages, ensuring high-quality results. Collaborate with other team members to coordinate laboratory tasks.
• Prepare risk analyses and troubleshoot complex problems.
• Design, prepare, and execute complex studies under supervision.

Our expectations

• University degree in a relevant field (e.g., biology, biochemistry, pharmacy, chemistry).
• Prior experience in the pharmaceutical industry or laboratory work is required.
• Good communication and organizational skills; team-oriented with a collaborative approach to achieving group objectives.
• Good knowledge of MS Office (Word, Excel, PowerPoint) for document preparation, spreadsheet management, and presentations.
• Excellent command of English, both written and spoken, sufficient for preparing technical documentation.
• Knowledge of statistical data analysis.
• Good understanding of biosimilars; hands-on laboratory experience in technical development or regulatory-related tasks will be an additional asset.

What we offer

• Employment at a leading company in Polish biotechnology sector.
• Engaging and meaningful professional challenges.
• Competitive salary with annual and special occasion bonuses.
• Attractive benefits package, including:
  
  • Private medical care.
  • Life insurance.
  • Employee Pension Program (PPE) and Employee Retirement Support (PWE).
  • One additional paid day off per year.
  • Flex Benefits budget (choose from options like MultiSport or Pluxee lunch card).
• Financial support for skill development.
• Weekly fruit and vegetable days.
• Access to psychological support.

At Rezon Bio, we believe in diversity and equality. Our recruitment process is conducted in a fully transparent manner and with respect for non-discrimination principles – regardless of gender, age, orientation, gender identity, or other individual characteristics. We encourage all individuals who meet the requirements to apply, including women, men, and non-binary persons. What matters most to us is your experience, skills, and passion for achieving goals together!