MAIN RESPONSIBILITY:
- Set up the team and facility in Polpharma Biologics for production for clinical trials and commercial-scale DP production
- Supervise/manage a team of individuals and have responsibility for all activities to supporting GMP manufacture of clinical and future commercial supplies from within the new facility
- Set-up of Quality system in Production Department in close collaboration with the Quality Unit to ensure cGMP compliance with special emphasis to EMA and US FDA requirements
- Coordinate issue identification and corrective action plans and implement such plans to meet GMP requirements, resolve project "issues" and maintain business commitments
- Ensure introduction and implementation of state-of-the-art technologies to facilitate therapeutic biologics production
- Active participation in process development to ensure possibility to transfer technology to production
- Representing Polpharma in partnerships/joint development committees and professional societies
- Monitoring the production processes and process quality, and make improvements as needed
- Managing stock levels to meet production requirements, warehousing facility and logistics, mechanical reliability programs, supply chain budget, stock control and inventory levels of obsolete and slow moving stock, energy consumption, site security, waste generation & disposal, standard operating procedures, monthly inventory variance and all necessary performance documentation for employees on site (including identification of training needs)
- Performing all duties with respect to current GMP requirements and other pharmaceutical regulations and representing the company during regulatory inspections
- Daily cooperation with the Production Department, Quality Unit, the Research and Development Department, and co-workers
REQUIREMENTS:
- Master/PhD in Biotechnology, Biochemistry or related field
- Minimum 5 years of relevant experience in respectively similar position (experience with Biosimilars will be an advantage)
- Proven track record in the technical development and production of therapeutic proteins
- Experience in technology transfer and scale-up
- Experience with single-use production equipment
- Experience in managing teams with leadership and people development approach
- Fluent Polish and English
WE OFFER:
- Employment contract conditions in the dynamic work environment of pharmaceutical company
- Attractive compensation package and benefits adequate to qualifications an competitive to market offer
- Opportunity for professional development and training
