DSP Cell Culture Plant Senior Specialist (Duchnice) (female / male)

Department: IMS&T 

What the job is about

This position involves working in the production of modern biotechnology medicines. All work is performed according to Good Manufacturing Practice (cGMP) and in compliance with European and U.S. regulatory requirements (EMEA and FDA).

The main goal of the role is to ensure that production processes run correctly, safely and consistently, and that the final product meets quality requirements.

Main responsibilities

• Supervising and monitoring the production process of the drug substance using mammalian cell culture

• Supporting improvements and optimization of production processes

• Participating in technological trials and testing new solutions

• Supporting technology transfer from laboratories or other manufacturing sites to production scale

• Continuous monitoring of processes and responding to any issues

• Preparing, reviewing and maintaining production documentation in line with Good Manufacturing Practice (GMP)

• Participating in deviation investigations and implementing corrective and preventive actions (CAPA – Corrective and Preventive Actions)

• Participating in process validation and qualification of equipment and systems

• Working closely with Production, Quality, Engineering and project teams

• Participating in internal and external audits and inspections

• Developing procedures and instructions and delivering trainings

Requirements

• University degree in biotechnology, biology, chemistry or a related field

• At least 4 years of experience in the biopharmaceutical or pharmaceutical industry

• Experience working with recombinant proteins (proteins produced using genetic engineering)

• Knowledge of mammalian cell culture processes

• Experience with single-use systems (SU) and stainless-steel systems (SS)

• Experience in buffer and solution preparation

• Knowledge of Good Manufacturing Practice (cGMP) and regulatory requirements (EMEA, FDA)

• Very good command of English, both written and spoken

• Good work organization, independence, problem-solving skills and ability to work in a team

What we offer

• Work on innovative biotechnology medicines

• Private medical care
• Supplemental life insurance
• Flexible Flex Benefits system with a monthly budget
• Cafeteria platform
• Employee Pension Scheme (PPE) and Employee Pension Support (PWE)
• Accident insurance for employees' children
• Occasional Bonuses
• Extra day off per year
• Free employee transport (Duchnice)
• Co-financing of training and upskilling
• Fruit and vegetable days
• Employee canteen with hot meals and live cooking (Duchnice)
• Psychological support
• Office massages
• Co-financing of leisure for employees and their children
• Benefits from the Social Insurance Fund
• Occasional gifts.

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!