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The main responsibility will be to execute and supervise Physicochemical activities related to in-process control analytics to support process development experiments, as well as development and qualification and/or validation of new analytical methods or optimization of existing ones within the Technical Research and Development department.
Specialist will be involved during the entire sample lifecycle: sample request, collection of the samples, preparation and running of the sample analysis, reviewing of results, communication with other departments, and delivery of the results on time. Will be also involved in the writing and revision of technical documents.
In this position, will be also responsible for training other team members in different techniques required and in process development steps.
- Conducting analytical method qualification and method transfer to Quality Control section or other external company.
- Performing analysis of Physicochemical methods, including HPLC, UPLC, CE, and other instrumental techniques required for analytical control of active substance and the drug form during its development and during technical batch runs.
- Analyzing and interpreting the research results carried out during development and technical batch runs. Performing results processing and interpretation (including peak integration, discussion of the results with the process development team, and identification of unexpected results).
- Keeping records of the research carried out, transfer/or qualification/validation of methods by existing standard operating procedures.
- Compiling results, justification of results and methods, impurities characteristics, and others. Reporting results and conclusions during group, project, and other meetings.
- Preparing analytical documentation as per requirement. Writing technical documents, standard operating procedures, and instructions.
- Conducting root cause analysis related to unexpected results obtained during process development including equipment, methods, and samples.
- Actively participate in process development samples lifecycle: sample request, collection of samples, preparing and running the samples analysis, reviewing of the results. Discussion and delivery of the results to other departments.
- Perform maintenance, calibration and qualification of physicochemical equipment in accordance with instructions and procedures.
- Writing User Specification Requirements (URS) and participation in the equipment purchase process, as well as User Manuals for new equipment.
- Controlling the usage and preparation of purchasing requests and supporting materials as well as substances and reagents used during the research. Check and organize the required consumables and reagents for required activities with the help of technicians.
- Providing training and support to the Junior Specialists, assistants, and technicians.
- Supporting team members’ work in preparing documents such as SOP, protocols and reports and daily laboratory activities.
- Participating in the organization of the in-process analytics in terms of equipment, sample management and operators.
- Supporting activities related to the continuous improvement of Analytical
- Development Laboratory wih the use of good laboratory practices as well as organizational and safety standards.
- Support for cGMP production and QC in methods transfer, validations, investigations, deviations, and change control assessment under the guidance of Senior specialists and Team Leader.
- Carrying out activities to ensure the laboratory’s functioning by the principles of health and safety, data integrity (ALCOA), hygiene, environmental protection, and 6S.
- BS/MS level with 3+ years’ experience in a Biopharmaceutical company.
- Experience in analytical techniques such as: HPLC, UPLC, Capillary electrophoresis, UV. Industry experience.
- Proven experience with HPLC/UPLC data analysis software (Empower) and data interpretation.
- Hands-on experience in routine analysis of samples coming from mAb process development will be beneficial.
- Experience in troubleshooting and route cause analysis related to unexpected results and equipment malfunctioning.
- Experience in writing procedures, protocols, and reports.
- Experience training junior staff and individual contributors.
- Basic knowledge of regulations and guidelines for good laboratory practice (GLP) and Good Manufacturing Practice (GMP) contained in the ICH, FDA, EMEA, and national guidelines.
- Fluent in English spoken and written.
- Fluent MS Office skills.
- Good organization of work and time.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- International work environment.
- Additional free day.
- and more…
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Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.