Requirements: English
Company: Polpharma Biologics
Region: Ozarw Mazowiecki , Masovian Voivodeship
Your responsibilities include, but are not limited to:
- Coordinating and planning the work and laboratory activities of the Analytical Development Physicochemical team at Polpharma Biologics (Duchnice);
- Supervising and supporting the laboratory work of Junior Specialists and Specialists;
- Reporting the progress of work in projects during group, project and other meetings;
- Leading, designing, developing, qualifying/validating and executing various Physicochemical assays to characterize and assess the structure, purity, heterogeneity, and PTMS of different biopharmaceutical products within the Technical Research and Development department;
- Coordinating the process of creating and implementing protocols, reports, methods, procedures and other documents required by internal regulations and procedures;
- Analyzing and interpreting the research results carried out during development, qualification, tech transfer and technical batch runs;
- Conducting root cause analysis and troubleshooting related to unexpected results obtained during process development, method development and qualification, including equipment, methods, and samples;
- Preparing presentations and reporting results and conclusions during group, project, and other meetings;
- Preparing analytical documentation as per requirement, including writing technical documents, standard operating procedures, and instructions.
- Controlling the usage and preparation of purchasing requests and supporting materials as well as substances and reagents during the research. Checking and organizing the required consumables and reagents for required activities with the help of technicians;
- Providing training and support to the Junior Specialists, Specialists, assistants, and technicians;
- Supervising the compliance of the work carried out in accordance with internal Quality System and procedures;
- Carrying out activities to ensure the laboratorys functioning by the principles of health and safety, data integrity (ALCOA), hygiene, environmental protection, and 6S;
- Supporting cGMP production and QC in method transfer, validations, investigations, deviations and change control assessment;
- Supporting analytical methods tech transfer between sites;
- Supporting the Team Leader in delegated activities.
If you have:
- Minimum 4+ years experience in an analytical laboratory in a pharmaceutical or biotech company;
- Bachelors degree in a science/health-related field is preferred (Masters or doctorate degree is an advantage);
- Leadership and organizational ability;
- Knowledge of analytical techniques such as liquid chromatography, electrophoresis, mass spectrometry, UV/VIS;
- Knowledge of topics related to GxP;
- Experience in writing procedures, protocols and reports;
- The ability to think creatively and collaborate with others to solve technical problems;
- Good organization of work and time;
- Knowledge of MS Office;
- Very good command of spoken and written English.
What we offer:
- Competitive salary;
- Private healthcare;
- Life insurance;
- Pension plan above national standards;
- Additional free day;
- and more..
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