Analytical Validation 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 diseasesThe Role
The Analytical Validation Expert is a Subject Matter Expert (SME) and will be part of the Late Stage CMC team leading the development and validation of Genmab’s antibody pipeline programs heading to regulator marketing approval. The Analytical Validation Expert will be part of a project team headed by a CMC Project Manager and working jointly with other SME’s for e.g. antibody drug substance process validation and sterile fill process validation.Key Accountabilities
The Analytical Validation Expert will be responsible for the following:
- Day to day oversight of analytical characterisation and analytical validation work performed at our CMO partners.
- Ensuring that Genmab’s products going through validation activities will be performed according to latest industry standards and regulatory guidance.
- Be the Genmab representative at the CMO during pre-approval inspections.
- Working closely together with relevant SME’s within jointly developed partner programs.
- Travelling up to 30 days per year as part of their work schedule.
In addition, the maintenance and development of CMC Operations Quality System as well as authoring and reviewing regulatory CMC submissions related to analytical validation activities is a part of the role.
Skills & Experience
- You have a minimum of a MSc qualification in relevant natural science subject.
- You have at least 5 years of experience within the biotech or pharmaceutical industry.
- You have active and recent experience within analytical characterisation and validation of methods for biologics/monoclonal antibodies from a phase II/III program, preferably from a marketed product.
- You have a thorough understanding of the detailed requirements for analytical validation.
- 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 (firstname.lastname@example.org).
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To learn more about Genmab, you can visit our website: http://www.genmab.com/