QC Senior specialist / Expert - Bioassay
Gdańsk
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities:
- Execute the team to ensure that priorities for lab scheduling, logistics and flow of activities for testing and review are established and followed and that workload is also prioritized, and staffing is maximized to ensure timely and effective performance
- Provides direct supervision of QC analysts performing routine GMP testing of potency, bioassay, ELISA and related methods, assuming primary responsibility for communication of requirements and expectations of the employee’s daily job
- Assures that analysts are trained on the relevant equipment and methodology, and that equipment is maintained and used properly
- Provides first line troubleshooting as needed, and reviews related Quality event records (e.g., Deviations and CAPAs)
- Assists in designing and continuously improving Quality Control systems, processes and procedures
- Writes and reviews departmental and interdepartmental SOPs covering analytical methods and general policies
- Reviews, analyzes and trends laboratory data that may include raw material, in-process, lot release, and/or stability testing. Regularly reviews system suitability trend data within area of analytical division and assists with investigation of out of trend situations
- Assists with developing, establishing, transferring, and validating testing methodology
If you have:
- MS degree in the biological, biochemical or related sciences with generally 5 + years of experience in the Bio/Pharmaceutical industry
- Experience in development and optimization of ELISAs and cell-based assays
- Experience in the design and optimization of potency and infectivity assays for AAV gene therapy products preferred
- Working knowledge of molecular-based (PCR) assays
- Prior experience working in GMP environment is required
- Experience using Quality System processes, and functional knowledge of Quality and Compliance is required
- Experience working with CMOs/external partners
We offer:
- Competitive salary
- Private healthcare
- Life insurance
- Pension plan above national standards
- Relocation package
- Additional free day
- and more