Senior Scientist

_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.