Physicochemical Specialist (f/m/d) (Maternity cover) (Gdańsk)

The Physicochemical Analysis Specialist is responsible for performing routine analytical activities during process development at laboratory and pilot scale, as well as pre- and post-commercialization studies of medicinal products. The role involves maintaining the continuity and compliance of Analytical Team laboratories with current quality standards. You will also be involved in the development, qualification and/or validation, and transfer of new analytical methods, or modification of existing methods, for pharmacologically active biological substances and medicinal products, to support registration, preclinical studies, and scale-up activities.

Your responsibilities

• Work in accordance with the quality procedures applicable at Polpharma Biologics.
• Strictly adhere to Health and Safety (HSE) rules.
• Perform analytical testing during process development and technical scale-up.
• Analyze and interpret results from development and technical scale studies in accordance with relevant documentation and guidelines.
• Review specialist literature to expand knowledge and learn new analytical techniques.
• Maintain documentation of studies, method transfers, qualifications, and/or validations in compliance with operating procedures and data integrity requirements.
• Conduct studies related to the development and/or modification of analytical methods for active substances and biotechnological medicinal products.
• Carry out qualification and/or validation of developed methods and transfer them to the Quality Control department or external companies.
• Prepare analytical documentation required for the manufacturing process and implementation of new biotechnological drug forms (e.g. methods, data summaries).
• Develop standard operating procedures (SOPs), instructions, and provide related internal training.
• Support general laboratory maintenance and help ensure the laboratory meets the requirements of internal and external regulatory bodies.
• Oversee calibration and qualification status of small analytical equipment (e.g. balances, pH meters, conductivity meters).
• Monitor usage and request supplies of direct and auxiliary materials, and substances and reagents used during analyses.
• Present research findings in Polish and/or English.
• Conduct internal trainings on analytical methods and good laboratory practice.
• Participate in audits as a subject matter expert in analytical methods and SOPs (as appointed by the supervisor).
• Collaborate with all departments within TR&D, Production, and Quality Control during project implementation; with Quality Assurance during documentation preparation; with Purchasing and Laboratory Warehouse Team for material and reagent procurement and equipment purchases; and with IT, Occupational
• Health & Safety, and Environmental Protection.

Our expectations

• University degree in chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine, or a related field.
• Knowledge of analytical techniques such as liquid chromatography, electrophoretic techniques, UV/VIS spectroscopy, and mass spectrometry.
• 2–5 years of experience in an analytical laboratory and/or quality control within a biotechnology or pharmaceutical company.
• Familiarity with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations and guidelines (ICH, FDA, EMEA, and national).
• Communicative knowledge of English (spoken and written).
• Excellent command of MS Office.
• Good organizational and time management skills; ability to collaborate effectively with others to solve problems.

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!