Subject Matter Expert – Downstream Processing
|Location:||Copenhagen , Hovedstaden|
Job SummaryAbout Us
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 CMC area of Genmab is growing and looking for a Subject Matter Expert (SME) – Downstream processing to join the CMC, Late Stage Manufacturing Development Team.
As SME Downstream Processing 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. upstream 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 process validation activities will be performed according to latest industry standards and regulatory guidance. As such, a thorough understanding of risk-based approaches (e.g. FMEA) together with an in-depth knowledge of downstream process characterisation is expected.
The SME will be responsible for the day to day oversight of the development, characterisation and process validation of downstream processing work performed at our CMO partners and will be the Genmab representative at the CMO during pre-approval inspections.
In addition, authoring and reviewing regulatory CMC submissions related to process validation activities is a part of the role.Key Accountabilities
- Responsible for the oversight of the development, characterization and validation of downstream processes at partnered CMOs
- Ensure characterisation and process validation of downstream processes 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 from the CMC area and understand the interphase between development and commercial.
- You have active and recent experience within development, characterisation and validation of downstream processes
- You preferably have active and recent experience with current regulatory requirements for viral clearance studies
- Excellent communication skills in both English and Danish, written and oral.
Moreover, you meet the following personal requirements:
- You are focused on achieving goals that are important for the team and our organization.
- You are pro-active, take initiative and responsibility
- With your positive attitude you enjoy working in multicultural teams inside and outside of Genmab
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 Jannie Jensen, recruiter Genmab (firstname.lastname@example.org)
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