Analytical Specialist

Job Description/ Responsibilities:

• Participation in R&D laboratory work related to project implementation, including:
  • Development and implementation of analytical methods including validation, verification, and transfer of physicochemical methods, with a focus on liquid chromatography methods;
  • Preparation of quality and analytical documentation – test methods, validation or verification protocols and reports, and method transfer documentation;
• Collaboration with the Team Leader during the execution of research projects;
• Performing release testing of raw materials and finished products according to approved methods and GMP procedures;
• Development and implementation of GMP documentation within the Laboratory’s scope;
• Recording and managing analysis documentation in accordance with GMP requirements and internal procedures;
• Conducting stability testing, reporting, and evaluation of results;
• Participation in OOX investigations and deviation handling in the Laboratory;
• Managing sample-related documentation for both incoming and outgoing samples;
• Operation and supervision of laboratory equipment;
• Preparing equipment for inspections and notifying supervisors about required maintenance, service, or repairs;
• Participation in the implementation of corrective actions based on findings from internal or external audit reports.

Requirements:

• University degree in chemistry, biotechnology, chemical technology, or related field;
• Minimum 2–3 years of experience working in an analytical laboratory (experience in clinical production and GMP environment is a plus);
• Knowledge of GMP guidelines and ICH Q2 related to analytical method validation;
• Experience in the development and validation of analytical and bioanalytical methods (experience in oligonucleotide analysis is a plus);
• Hands-on experience with analytical techniques such as HPLC/UHPLC, especially with detectors: MS/FLD/CAD, as well as spectrophotometric and spectrofluorometric techniques;
• Ability to work with GMP documentation (protocols, reports, deviations, CAPA, OOX);
• Good organizational skills;
• Ability to work in a team;
• Accuracy and responsibility for assigned tasks;
• Analytical thinking skills, ability to interpret results and draw conclusions;
• Proactive attitude, willingness to learn, and problem-solving mindset;
• Good command of English (minimum B2 level);

What we Offer:

• Benefits package (medical, sports, life insurance);
• Extensive social benefits, including holiday subsidy (“wczasy pod gruszą”);
• Opportunity to participate in shaping standards in a newly developing organization;
• Interesting work in an innovative company offering breakthrough biotechnological solutions across various market segments;
• Independence in the role, decision-making authority, and ability to implement your own solutions;
• Career advancement opportunities as the organization grows.