Senior Scientist Drug Product Development - Unique Human Capital
Unique Human Capital A/S
Take part in an exciting journey of antibody drug product development aiming at improving patients’ health
Symphogen is in an exciting phase as the Antibody Center of Excellence in Servier with a continued focus on the development of antibody-based therapeutic products for the treatment of cancer and inflammatory/autoimmune diseases.
With direct report to the Team Manager Stability & Formulation in Drug Product Development, you will work with broad responsibilities within the development projects, and based on your scientific background and experience, you will be more heavily involved in formulation development, process development, manufacturing, or stability studies.
The Drug Product Development department is part of the CMC function at Symphogen, which is integrated with the Servier CMC group in a strong international collaboration. Together, they support projects in all phases of development, from early discovery to process validation and beyond.
To ensure development progress, you will collaborate closely with staff from the CMC Biologics group and be a member of international cross-functional project teams.
In the Drug Product Development Department, the team is responsible for:
- Drug product process development
- Oversight of clinical manufacturing of liquid and lyophilised products
- Formulation development
- In-use compatibility studies
- Stability studies for drug substances, drug products, and reference material
- Authoring regulatory documentation for the authorities
- Coordination of drug product activities in CMC project groups
Your qualifications include a proven track record in biologics drug product development, in-depth knowledge of proteins' physical and chemical properties, and significant experience in developing biopharmaceutical parenteral drug products. You have an interest in drug product process development and manufacturing. In addition, a strong foundation in stability and/or formulation is preferably needed.
You are knowledgeable about GMP and regulatory requirements associated with biologics drug development. Ideally, you have knowledge about antibody-drug conjugate drug product development and have experience with lyophilised formulation development and/or combination products.
You have a relevant degree, such as a cand.pharm., cand.scient., cand.polyp., or equivalent, and you have strong communication skills in English, both verbally and in writing.
You are a person who is proactive and thrives in a dynamic and diverse work environment. You have a pragmatic mindset, natural project management abilities, and a strong capacity for effective teamwork with a great sense of humour.
Being part of Symphogen, you will have a challenging job in a creative, goal-oriented, and value-based environment with a meaningful mission: to advance superior monoclonal antibody therapeutics to improve the lives of cancer patients. You will be a part of a highly engaged and inspiring organisation focusing on diversity, teamwork, commitment – and on you as a person. You will be offered good development opportunities and a relevant benefit package.
Domicile: Ballerup, Denmark.
At Unique Human Capital, we are committed to promoting diversity and including all perspectives. Thus, we encourage all qualified candidates to apply for the position.
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Symphogen A/S is a Servier company and the Antibody Center of Excellence operating within research, clinical stages, and CMC biologics development. They support Servier’s commitment to improving patients’ health and the R&D strategy within oncology, immune-oncology, and immunoinflammatory diseases.
Symphogen’s strategic focus is to apply a streamlined and effective antibody platform and capabilities to discover and develop novel and innovative antibody therapeutics. Symphogen aims to continuously build antibody technologies and provide new discoveries and early development therapeutic antibody compounds as combination or stand-alone therapies.
Symphogen is located in Ballerup, in the greater Copenhagen area. The company currently employs approximately 150 people.
Read more at https://www.symphogen.com/
Adresse:
Ballerup, Denmark
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