Job responsibilities

• support to the pilot plant construction project in the design, commisioning, qualification and validation of production lines
• control and maintenance of routine operations in the pilot plant, with the aim that new projects are started according to plan, that ongoing activities are completed on time and that the results are within the quality expected by the customer
• support to performance qualification and process validation implementation
• ensuring that the pilot plant operates in an environment of good manufacturing practice, that tasks are performed, and documentation is completed in a consistent manner
• cooperation in the transfer of technologies and maintenance of operational readiness for the introduction of new production processes and new lines in order to ensure the possibility of increasing series and reproducibility of processes,
• use of expert knowledge and experience in the field of organic synthesis, process development and scale-up to eliminate technical problems and optimize reaction conditions
• ensuring compliance with regulatory requirements, including FDA regulations, ICH guidelines and customer specifications. Implementation of measures to monitor and control the quality, purity and yield of the product throughout the entire production process
• conduct regular checks and audits to identify areas for improvement and ensure ongoing compliance with quality standards
• participation and contribution to the selection process of new team members of the pilot plant and taking responsibility for the personal development and performance management of all team members
• promoting a safety culture in production and spreading it to other functions in the company.

What we expect

• university degree in chemistry, chemical engineering or a related field with experience in the field of pharmaceutical development or production
• demonstrable experience in chemical operations, process development/manufacturing and batch scale-up
• in-depth knowledge of GMP regulations, quality systems and regulatory requirements for pharmaceutical production
• practical experience with analytical techniques, process optimization and troubleshooting in the field of organic synthesis
• active knowledge of the English language.

Our offer

• an employment relationship for an indefinite period with a trial period,
• a dynamic and stimulating work environment where we give priority to knowledge and professional competences,
• the possibility of actively co-shaping the company and introducing new ideas,
• the opportunity to acquire extremely important career knowledge and experience,
• a responsible position that offers excellent conditions for professional growth and career development in an international environment.

Is this job a challenge for you? You are invited to submit an application at jobs@portonpharmatech.com

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