Production Senior Specialist/Expert

Your role

In this role, you will manufacture biotechnological products in strict adherence to cGMP and regulatory standards set by the FDA and others to ensure high quality and efficacy. You will enhance and refine production processes by identifying improvements and implementing solutions collaboratively across various departments and Polpharma Biologics group plants. Your duties will also involve participating in technology transfers and project management for the introduction of new products, ensuring compliance with legal and internal SOPs.

Your responsibilities

Production Management:

• Supervise and monitor the production of biotechnological products per GMP and internal standards.
• Lead production process optimization and conduct technology trials.
• Assist in technology transfers and process implementation for the production of active substances.

Quality Assurance and Documentation:

• Contribute to pre-validation/validation strategies and process monitoring.
• Review and coordinate registration documents; provide input on user requirements and quality standards.
• Manage documentation, participate in investigations, change controls, risk assessments, and CAPA implementations.
• Develop and verify SOPs, manuals, and qualification documentation.

Collaboration and Compliance:

• Support audits/inspections, report abnormalities, task progress, and status to supervisors.
• Collaborate closely with Production, Engineering, and Quality departments to ensure efficient task completion.

If you have

• Experience with recombinant proteins and large-scale production.
• In-depth knowledge of protein chemistry, cell behavior, and metabolism.
• Familiarity with USP processes like cell banking, bioreactor operations, and primary recovery.
• Experience in process validation, equipment/systems qualification, and cGMP and FDA standards.
• Proficiency in English; excellent organizational, problem-solving, and team skills.

We offer

• Competitive salary;
• Private healthcare;
• Life insurance;
• Pension plan above national standards;
• Relocation package;
• Additional free day;
• and more...