The CMC area of Genmab is growing and looking for a Subject Matter Expert (SME) – Upstream processing to join the CMC, Late Stage Manufacturing Development Team.
As SME you will be part of a highly dedicated and specialised CMC team leading the late stage development activities of Genmab’s proprietary antibody pipeline programs towards marketing approval (BLA/MAA).
The SME will work across project teams to support the CMC Project Managers and work closely with other SMEs for e.g. downstream processing, analytical validation and characterization as well as with relevant SMEs within jointly developed partner programs.
The SME will ensure that Genmab’s products going through the late stage development activities will be performed according to latest industry standards and regulatory guidance. As such, a thorough understanding and overview of mammalian upstream processes together with an in-depth knowledge of upstream process characterisation, and validation activities is expected.
The SME will be responsible for defining the scope of the late stage development activities such as upstream process characterization and process performance qualification performed together with our CMO partners.
In addition, authoring and reviewing regulatory CMC submissions related to upstream process activities is a part of the role.
- Responsible for the oversight of the upstream development, characterization and validation of upstream processes at partnered CMOs
- Ensure upstream late stage activities, such as risk assessments, process characterisation and process performance qualification are performed according to industry standard, fulfilling latest regulatory requirements
- Prepare/review technical documents including development /tech transfer reports, batch records, SOPs and CMC regulatory submissions.
- It is expected that you have a master’s degree in science, pharmacy or similar.
- You have at least 5-10 years of documented professional experience with mammalian upstream processes from the CMC area and understand the interphase between early and late stage development.
- You have active and recent experience within late stage development of upstream processes
- Excellent communication skills in both English and Danish, written and oral.
Moreover, you meet the following professional requirements:
- You are focused on achieving goals that are important for the team and our organization.
- You have the ability to work successfully under pressure in a fast-paced environment and with tight timeline
- You are pro-active, take initiative and responsibility
- You are a team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders
- With your positive attitude you enjoy working in multicultural teams inside and outside of Genmab
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.