Senior Scientist mfx Conjugation and Purification
Senior Scientist mfx Conjugation and Purification
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Job Description
Simtra BioPharma Solutions (Simtra) is a worldclass 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 prefilled syringes liquid/lyophilized vials diluents for reconstitution powderfilled 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 lifechanging medicines to patients worldwide.
At our plant in Halle/Westphalia we produce for the treatment of various cancers and other lifethreatening diseases.
In the role of Senior Scientist (m/f/x) Conjugation and Purificationyoure responsible for the development and optimization of the conjugation and purification platform for the Halle (Westphalia) site. This will support our new precommercial suite in AntibodyDrug 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 precommercial 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 youll 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 AntibodyDrug 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
- Inhouse modern canteen with attractive subsidy
- Job bike leasing
- Good transport connections and free employee parking spaces with echarging stations at favorable conditions
- Free company sports e.g. badminton soccer and fitness classes
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:
Senior IC
Employment Type
Full Time
