- Perform and document biological analyses of products and active substances (ELISA, qPCR, cell‑based assays) in accordance with applicable GMP/GLP standards and pharmacopoeial requirements.
- Validation and transfer of analytical methods, as well as acting as an SME.
- Reviewing laboratory documentation for compliance with GMP, GDocP, and data integrity principles.
- Oversight of laboratory equipment and collaboration with QA/QC.
- Working with LIMS, SAP, QMS, EMS systems and preparing documentation in DMS.
- Participation in change controls, TWD activities, handling quality events, and conducting investigations (deviations/OOX).
- Participation in audits and implementation of post‑audit recommendations.
- Preparing risk assessments and initiating improvements (GMP, technical, organizational).
- Training employees and collaborating with internal and external stakeholders.
Requirements
- Higher education in biotechnology, biology, or related fields.
- Minimum 5 years of experience in an analytical/bioanalytical laboratory or quality control laboratory within the pharmaceutical or biotechnology industry.
- Strong hands‑on experience performing tests using core molecular biology techniques, particularly ELISA and/or qPCR (mandatory).
- Expert analytical knowledge and familiarity with analytical and instrumental techniques.
- Knowledge of pharmacopoeial guidelines and GMP, EMA, FDA, and pharmaceutical law regulations.
- Very good command of English, both spoken and written.
- Ability to plan effectively, set priorities, and manage multiple tasks simultaneously.
- Ability to clearly report and present results, with strong communication skills.
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 Higher Pension Package (PWE).
- One additional paid day off per year.
- Flex Benefits budget (choose from options like MultiSport or Pluxee lunch card).
- 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!