(+45) 29 44 00 80 / kontakt@beirholmsearch.dk

Quality Assurance Specialist

Quality Assurance Specialist
marts 19, 2021 Hanne Beirholm
job Symphogen logo big gray beirholmsearch

…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.

Symphogen QA are involved in every step of the biomanufacturing process from generation of cell banks, upstream and downstream processes, final formulation and filling, analysis, packaging, and release of the Investigational Medicinal Product (IMP). We are a highly motivated, experienced small team that work in strong collaboration with the scientist to secure compliance of processes and products according to authority rules and guidance for the patient’s benefit and safety.

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 specialist groups 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, preferred the biopharmaceutical industry
Up to date GMP knowledge, including the 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

We offer

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 Beirholm Search, email: kontakt@beirholmsearch.dk or Hanne Beirholm at +45 29440080.

The Company:

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.

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