Manager (m / w / d) Analytical Services New Business

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington Indiana US and Halle / Westfalen Germany we offer a wide range of delivery systems including pre-filled syringes liquid / lyophilized vials diluents for reconstitution powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules cytotoxics highly potent compounds diluents for reconstitution and vaccines which are all directly injected into patients worldwide. As such there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing we offer many support services including formulation and development lyophilization optimization global regulatory support and secondary packaging. Our teams are driven to help clients scale innovate and bring life-changing medicines to patients worldwide.

At our plants in Halle / Westphalia and Bloomington / Indiana we produce drugs for the treatment of various cancers and other life-threatening diseases.

In the role as a Manager (m / w / d) Analytical Services New Business your overall focus is the management of analytical services in manufacturing projects including method validation documentation client coordination and audit support.

In your new role you will be empowered to :

• Responseability for the project management of analytical services for the new business
• Validation Transfer and Verification of analytical methods for contract manufacturing projects
• Preparation of analytical documents (test methods specifications protocols plans reports) for contract manufacturing products and raw materials
• Planning and support of stability- compatibility- and other analytical studies
• Pharmaceutical evaluation of the above-mentioned activities within the project management team
• Support of analytical deviation investigations with respect to risk assessment root cause analysis and corrective / preventive actions
• Processing of client requests
• Implementation of client requirements regarding analytical issues
• Cost calculation of analytical services
• Project management of analytical services (responsibility for timelines milestones and costs)
• Representation during audits and client visits

What youll bring :

Benefits :

We offer interesting opportunities to committed and talented people. Gender age skin color origin sexual orientation and disabilities do not play a role - on the contrary : we promote diversity and believe that diversity is an enrichment.

We look forward to receiving the documents relating to your professional career directly via our online system.

If you have any questions please contact Selin Sencan ().

To learn more about Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy : Privacy Policy (DE) Simtra BioPharma Solutions

Required Experience :

Manager

Key Skills

Accounts Assistant Credit Control,Autocad Design,Corporate Risk Management,Lab Testing,AC Maintenance,Accident Investigation

Employment Type : Full Time

Experience : years

Vacancy : 1