Senior Scientist (m/f/d) Development and Pre-commercial Service

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 plant in Halle/Westphalia, we produce drugs for the treatment of various cancers and other life-threatening diseases. 

In the role of Senior Scientist (m/f/d) Development and Pre-commercial Services, you’re responsible for the development and optimization of the conjugation and purification platform for the Halle (Westphalia) site. This will support our new pre-commercial suite in Antibody-Drug Conjugates (ADCs) development. You will ensure technical and scientific expertise, further development, innovation and continuous improvements of the technological platform.

Furthermore, the tasks include:

• Lead of the scientific proposition for the site
• Managing a team of operators in manufacturing pre-commercial or commercial products
• Support people development and promote a culture of collaboration
• Establishment of development capacities and subsequent support at all sites
• Continuous development in close cooperation with our customers
• Oversee the change control process with customers and internal teams
• Identification of opportunities for improvement
• Responsibility for compliance with regulatory requirements and GMP standards to drive high quality and safety standards
• Risk and CAPA management and related remediation strategy development
• Regular reporting and escalation to the leadership team
• Support and development of new technologies such as digital twin or enhanced DOE analysis
• Coordination and control of scope changes
• Conduct presentations and participate in conferences and meetings in the scientific community

What you'll bring:

• PhD in biotechnology, chemistry or biology required
• At least 5 years of professional experience in a research or development environment
• Experience in interacting with customers and with Antibody-Drug Conjugates (ADCs) preferred
• Strong communication and interpersonal skills, able to effectively interact with and influence stakeholders at all levels
• Demonstrated ability to lead collaborative initiatives and promote a culture of continuous learning and excellence
• Computer proficiency in Microsoft Project, Word, Excel, and Outlook and the ability to use enterprise software tools
• Fluent in German and proficient in written and spoken English

Benefits:

• An attractive salary and 30 days' vacation
• An efficient and pleasant working environment in a team that is looking forward to meeting you!
• In-house modern canteen with an attractive subsidy
• Job bike leasing
• Free company sports, e.g. yoga, squash and fitness courses

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 (ssencan@simtra.com)

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