Analytical Method Validation Senior Specialist (Bioanalysis) (f/m/d) (Gdańsk)

About the Role

The person in this role will provide comprehensive support for the implementation of bioanalytical methods and the strategy for introducing new biological products. You will be responsible for key QC activities related to method validation, method transfer, and the implementation of new bioanalytical techniques, ensuring full compliance with regulatory guidelines and GMP principles.

Main Responsibilities

• Performing and verifying activities related to the implementation, validation, and transfer of bioanalytical methods, including liquid chromatography (HILIC, Sialic acid, Neutral sugar, Peptide Mapping, Oxidation, SEC, CEX) and capillary electrophoresis (CE‑SDS, cIEF), in accordance with regulatory guidelines and GMP requirements.
• Preparing, reviewing, and maintaining documentation, including protocols, reports, methods, procedures, and training materials.
• Proposing and implementing process improvements to increase efficiency and ensure effective project execution.
• Providing technical expertise and conducting training for QC team members in new bioanalytical methods.
• Close collaboration with the Product Development Department, QC Laboratories, and the Procurement Department to support project execution and ensure material availability.
• Monitoring and applying current regulatory guidelines related to bioanalytical methods, validation, and method transfer.
• Continuous development of technical skills and expanding knowledge of new bioanalytical techniques and industry standards.
• Ensuring proper and GMP‑compliant documentation practices.
• Participation in quality activities such as deviations, incidents, investigations, CAPA, and change control.

Requirements

• Higher education in biotechnology, biology, biochemistry, chemistry, or related fields.
• Minimum of 3 years of experience in a regulated laboratory environment (biotechnology laboratory preferred).
• Experience in validation or development/qualification of bioanalytical methods.
• Knowledge of regulatory guidelines related to bioanalytical method validation and transfer.
• Strong knowledge of bioanalytical methods, including liquid chromatography (HILIC, Sialic acid, Neutral sugar, Peptide Mapping, Oxidation, SEC, CEX) and capillary electrophoresis (CE‑SDS, cIEF — experience with the Maurice system would be an additional asset).
• Proficiency in Empower Chromatography Data Software and good knowledge of MS Office.
• Very good command of English, both spoken and written.
• Strong analytical thinking, problem‑solving skills, and ability to collaborate effectively in cross‑functional teams.
• Good knowledge of GMP and GDP principles and their practical application.

What we offer

• Employment at a leading company in Poland’s 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.
  • Free transportation to the workplace (2 dedicated lines).
  • On-site cafeteria serving fresh breakfasts and lunches, with live cooking once a week.
  • 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!