USP Process Specialist
Adamed is one of the 10 largest pharmaceutical companies operating in Poland and the leader in next-generation pharmaceuticals. We were the first Polish company to undertake research into innovative therapies back in 2001. We have invested 1.9 billion Polish zloty in research and development to date, and our portfolio currently boasts around 500 products. Adamed has been working with leading universities and scientific institutes in the homeland and abroad.
Department of Innovation, Adamed Pharma S.A. is looking for an enterprising and ready to challenges person for the position of Process Specialist for USP.
Location: Pieńków
Tasks
- Development and optimization of the USP process for biomolecules, both in the research and development laboratory and pilot production facility;
- Participation in technology transfer for process upscaling up to pilot level;
- Preparation of equipment qualification documentation in accordance with cGMP rules, participation in the qualification of equipment and systems;
- Supervision of equipment;
- Supporting workflow organization, developing procedures, SOPs and working in accordance with cGMP rules in the pilot part;
- Support in building a team dedicated to the production of a pilot scale, as well as in the creation and equipment of research laboratories and production and analytical facilities;
- Preparation of formal production documentation (CMC) in accordance with the GMP rules necessary for IMPD application to conduct clinical trials and registration of the final product;
- Collaboration with team members responsible for the DSP part, analytics, QA and QC, technical service, as well as project managers.
Requirements
- Higher education: biology/biotechnology or related;
- Minimum 3 years of experience in a similar position at CMO or another biopharmaceuticals producing facility;
- Knowledge of drug development and manufacturing processes and cGMP, GLP and EMA / FDA regulations for biopharmaceuticals;
- Experience in the production of biomolecules with the use of single use technology;
- Ability to operate biofermenters at least up to the pilot scale;
- Experience in managing and supervising process documentation;
- Experience in statistics and DoE issues;
- Good work organization, communication skills and independent problem solving;
- Very good or good knowledge of oral and written English;
- Knowledge of MS Office package.
We offer
- Employment based on a job contract with base salary and annual bonus;
- Hybrid work (4 days office / 1 day home office a week);
- Life insurance co-financed by the Employer;
- Private medical care for an employee as well as his/her family members;
- Extra social benefits (cafeteria of benefits, christmas gifts);
- Sharing costs of meals;
- Organized transport to the office from PL. Wilsona or parking space;
- Attractive employee refferal program.