Technology Transfer and Process Validation Expert

3 dni temu

Gdańsk, Pomerania, Polska Polpharma Biologics Group Pełny etat
Technology Transfer and Process Validation Expert

Boost your career with us at Polpharma Biologics, a biopharmaceutical company with state-of-the-art facilities across Europe. We specialize in cell line development, product and process development, clinical manufacturing, commercial scale production, and regulatory affairs. Together, we develop medicines, offering new hope to patients suffering from serious diseases. Join us in creating a passionate and friendly workplace environment

Are you passionate about cutting-edge biotechnology and eager to play a pivotal role in process transfer and validation? In this role, you will lead and coordinate process transfer and validation activities for monoclonal antibodies, enzymes, and other biotech products. You will ensure smooth technology transfer, compliance with cGMP regulations, and optimize production processes for efficiency and scalability. Your expertise will help drive innovation and excellence in the development of groundbreaking biosimilars.

Your responsibilities include, but are not limited to:
  • Lead and coordinate technology transfer and process validation activities for new biotech products.
  • Act as an interface between development and manufacturing.
  • Lead cross-functional project teams.
  • Analyze and review process design to ensure facility fit and GMP compliance.
  • Evaluate new technologies and define optimal platform solutions.
  • Develop and review key process transfer documentation (protocols, reports, risk assessments, and process descriptions).
  • Support deviation investigations, change control assessments, CAPA implementation, and GMP batch evaluations.
  • Coordinate and assess process feasibility for CDMO collaborations.
  • Create and review PV documentation including protocols and risk assessments related to PV.
  • Monitor and trend GMP and process validation data to ensure process robustness.
  • Propose process optimizations to enhance efficiency, reduce costs, and improve scalability.
  • Collaborate cross-functionally with production, quality, and R&D teams to ensure seamless process execution.
If you have:
  • A minimum of 6 years in biotech production, with hands-on experience in process transfer, process validation, and scale-up; a PhD degree is a plus.
  • A master's degree in Biotechnology, Pharmacy, or a related field.
  • Strong understanding of mammalian cell culture and/or microbial manufacturing processes, cGMP regulations, and global guidelines (FDA, EMA).
  • Excellent problem-solving, data analysis, and technical troubleshooting abilities.
  • Strong written and verbal communication skills, with the ability to work both independently and in a collaborative, fast-paced environment.
  • Experience with single-use technology and/or stainless steel technology.
  • Experience with technology transfer and process validation methodologies.
  • Ability to interact with different groups and teams: development, quality, QC, engineering, both internal and external (suppliers and/or clients) at various levels in the organization.
  • Ability to work under pressure, handle conflicting interests, and make decisions.
  • Ability to work independently under general direction while keeping functional management and the wider organization appraised of progress and potential risks.
  • Good sense of prioritization of assigned tasks and goals and managing time accordingly.
  • Drive for innovation and change to ensure competitiveness.
  • Intellectual curiosity, open and willing to learn.
  • Self-awareness and adaptability.
  • Good organizational and analytical skills.
  • Good command of the English language in both speaking and writing.
  • Strong communication skills and a proactive approach to problem-solving.
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