The position as Quality Assurance Specialist offers a unique possibility to be part of biotechnology development activities within both the early and late-stage projects of Symphogen’s antibody lead candidates. As QA specialist with focus on the CMC (Chemistry, Manufacturing, and Controls) area you will gain knowledge within all the processes and steps in the Investigational Medicinal Product development.
The QA Specialist will have a close collaboration with the Symphogen CMC teams managing process-and analytical development and validation, manufacture for clinical supply and the future market application processes.
Tasks and Responsibilities
The responsibilities include, but are not limited to:
- Participate in the further development and maintenance of the Symphogen Quality Management System and the integration with the Servier Quality Management System
- Participate in maintenance of the Symphogen Electronic Document Management System, Veeva Vault
- Participate in project development work with GxP QA expertise providing GMP compliance
- Supervise GMP manufacturing of clinical trial material at our CMO’s (Contract Manufacturing Organizations)
- Deliver support to the documentation management and review from suppliers and CMOs in order to ensure readiness for product release
The ideal candidate:
- University education in life science (MSc pharm or similar)
- Experience from the pharmaceutical industry, preferably the biopharmaceutical industry
- Up-to-date GMP knowledge, including current FDA, EMA, and ICH guidelines within the pharmaceutical area
- Interest in building up and streamlining processes and systems to support the quality system
- Fluent in Danish and English, verbally and in writing
- Is a strong communicator, who is able to listen, while at the same time being pragmatic and flexible in the approach to problems and challenges
- Is honest and openminded with a good sense of humor
- Work independently as well as part of a team
- A challenging and versatile job in an innovative, flexible, focused and committed biotech environment
- Competitive salary based on qualifications, and flexible working hours
- Strong cross functional teamwork, room for individual performance and development, passionate, inspiring, and fun colleagues
Working in Symphogen
Being part of Symphogen, you will always have a challenging job in a creative, goal-oriented, and value-based environment with a meaningful mission – to advance superior mAb therapeutics to improve the lives of cancer patients. You will be a part of a highly engaged and inspiring organization with focus on diversity, teamwork, commitment – and on you as a person. You will be offered good development opportunities and a relevant benefit package.
For further information
For more information you are welcome to contact Marianne Sort, QA Director, email: email@example.com or HR-Manager, Pia Holm Olesen at +45 4526 5050. Please also see www.symphogen.com for information about our company.
If you are interested in the position, please mark your application and CV “QA Specialist” and mail it to: firstname.lastname@example.org no later than 31. January 2021. Potential candidates will be invited for interview as they apply, and we reserve the right to terminate before the posting expires.
We look forward to hearing from you!
Symphogen is a subsidiary of Servier and antibody center of excellence primarily focused on oncology and immune oncology. We have a highly efficient antibody discovery and research platform supported by comprehensive early development capabilities.
Our antibody platform delivers antibodies with unique functionalities providing best or first in class potential as combination or mono therapy. Our approach and capabilities are well suited for combination therapies at the core of future cancer treatment.
Symphogen is located in Ballerup in the greater Copenhagen area. The company currently employs approximately 100 people