Product Characterization Expert
Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.The Role
The Product Characterization Expert is a Subject Matter Expert (SME) and will be part of the CMC Operations late stage team leading the development and validation of Genmab’s antibody pipeline programs heading to regulatory marketing approval.Key Accountabilities
The Product Characterization Expert will be responsible for the following:
- Oversight of product characterisation activities performed at Genmab CMOs and intern laboratories.
- Ensuring Genmab’s antibody products are being characterized according to latest industry standards and regulatory guidance.
- Ensuring relevant analytical methods are used in product characterization package
- Close collaboration with internal Genmab teams and supporting the CMC Operations department.
- Assisting in the maintenance and development of the CMC Operations Quality System.
- Authoring and reviewing regulatory CMC submissions related to product characterization activities.
- You have a minimum of a MSc qualification in relevant natural science preferably within protein science and characterization.
- You have at least 5 years of experience within the biotech or pharmaceutical industry.
- You have preferably active and recent experience within product characterization including forced degradation studies of biologics/monoclonal antibodies from a phase II/III program.
- You have a thorough understanding of antibody functionalities and their link to critical quality attributes.
- You have been preparing and reviewing relevant filing documentation for regulatory market authorizations (e.g. BLA).
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
If you would like additional information about this position before applying using the link, please contact Uthen Khamproh (email@example.com).
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To learn more about Genmab, you can visit our website: http://www.genmab.com/