Process Transfer and Validation Expert
Duchnice, PL
Join Rezon Bio, where biotech experts create biologics that improve lives worldwide - not by following the old rules, but by finding better, more reasonable ways to do things.
Built on the excellence of Polpharma Biologics, Rezon Bio is evolving into a Contract Development and Manufacturing Organization (CDMO) with a clear reason: to challenge the status quo and raise the bar in biotech.
With state-of-the-art centers in Gdańsk and Warsaw-Duchnice, we offer career opportunities across science, technology, and business for those who want their work to truly resonate.
Work alongside 1,300 professionals who combine global ambitions with local roots – driven by science, purpose, innovation, and respect for diversity.
About the Team
The IMS&T team is responsible for leading technology transfers of drug substance manufacturing processes and supporting the introduction of new products into commercial production. We work cross-functionally to ensure smooth, compliant, and timely execution of all transfer, validation and launch activities.
Your Responsibilities
- Lead and support end-to-end Technology Transfer activities as a receiving or sending manufacturing site.
- Coordinate all cross-functional workstreams involved in Technology Transfer, including Manufacturing, Quality Control, Quality Assurance, Engineering and Supply Chain.
- Act as the Single Point of Contact for assigned Technology Transfer projects.
- Develop technical strategies, risk assessments and contingency plans across the full project lifecycle.
- Prepare, review and oversee key Technology Transfer and process validation documentation (plans, protocols, reports, Master Batch Record inputs).
- Monitor process validation campaigns, assess the impact of deviations, provide validation status updates and support dossier preparation for regulatory authorities.
- Coordinate end-to-end readiness for manufacturing campaigns – documentation release, equipment and materials readiness, training and pre-campaign alignment.
- Lead interdisciplinary project teams (10–30 members), manage timelines and ensure compliance with Good Manufacturing Practice (GMP) and Environment, Health & Safety (EHS) standards.
- Assess site resource needs (FTEs, investments, external costs) and support budgeting for Technology Transfer projects.
- Represent the company during meetings with external clients and inspections by Health Authorities (HA).
- Contribute to continuous improvement of Technology Transfer processes, templates and procedures.
- Report project progress, key risks and decisions to the Senior Manager.
Our Expectations
- Higher education in biotechnology, pharmacy, or related fields.
- Minimum 5 years of experience in biotechnology or pharmaceutical manufacturing and/or technology transfer.
- Strong knowledge of GMP, EMA/FDA guidelines and technology transfer best practices.
- Experience in process validation and working with recombinant proteins at production scale.
- Excellent English skills, both written and spoken.
- Ability to work independently, solve problems, and collaborate effectively across teams.
- Proficiency in MS Office and MS Project.
We fuel your professional growth and back it with a comprehensive benefits package. Our advanced facilities support both commercial-scale production and cutting-edge R&D, making us one of the most modern biotech organizations in Europe.
Here your ideas resonate and drive meaningful change. With continuous learning opportunities, many experts have already found their reason to return or relocate to Poland and grow their careers with us.
Does this resonate with you?
Learn more at RezonBio.com/careers and on LinkedIn