Quality Control Stability Expert (f/m/d) (Gdańsk)

As a Quality Control Stability Expert, you will be the driving force behind our validation, registration, and stability studies. You’ll lead the planning, coordination, and execution of stability projects, ensuring scientific excellence and regulatory compliance. You’ll analyze data, define product shelf life, and prepare comprehensive reports, all while collaborating closely with teams across QC, QA, and regulatory affairs.

Your responsibilities

• Manage and conduct stability studies for medicinal products, focusing on biosimilars.
• Analyze study results, interpret data, and prepare summary reports.
• Define product shelf life based on scientific and regulatory guidelines.
• Train and support team members in stability study procedures.
• Monitor and implement changes in regulatory requirements.
• Lead and participate in audits and regulatory inspections.
• Develop strategies for continuous improvement of stability programs.
• Draft and review stability sections of regulatory dossiers (IMPD/IND/NDA).
• Support new IT system implementations and generate stability metrics for management.
• Organize and maintain stability documentation, manage quality events, and investigate deviations.
• Collaborate with sample management teams and external partners.
• Serve as a subject matter expert for internal and external stakeholders.

Our expectations    

• Higher education in biology, chemistry, pharmacy, or biotechnology.
• Minimum 5 years’ experience in stability studies, preferably with biosimilars and in a regulated environment.
• In-depth knowledge of GLP, GMP, GDP, and regulatory requirements for stability testing.
• Experience analyzing stability data and defining product shelf life.
• Familiarity with statistical tools and software (JMP knowledge is a plus).
• Excellent English (written and spoken).
• Strong analytical thinking, organization, and teamwork skills.
• Proficiency in MS Office.

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!