Team Lead, Late Stage Manufacturing Development
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 Late Stage Manufacturing Development Team Lead.
As Team Lead for the late stage development unit you will be responsible for establishing CMC strategies for our late stage programs. You will lead a highly skilled team of 7 CMC professionals, who possess a combination of analytical and process knowledge within late stage CMC development.
Besides having management responsibility, it is important that you actively share your knowledge of late stage CMC development in the project teams and support the process towards BLA filing. You will spend your time on people management activities and on project related activities.
As the new Team Lead you will be part of a large CMC organisation and report to the Vice President CMC.Key accountabilities:
- Responsible for Late Stage Manufacturing Development
- Develop analytical validation strategies for Drug Substance and Drug Product with the CMC PM and SMEs
- Develop process characterization and validation strategies for Drug Substance and Drug Product with the CMC PM and SMEs
- To ensure that validation strategies are in compliance with latest regulatory requirements
- Further develop Genmab’s approach to late stage manufacturing development
- Collaborate with our commercial function to establish processes for transfer from development to commercial
- Prepare launch readiness strategies in collaboration with commercial team
- Lead and manage a highly skilled Late Stage Manufacturing Development Team
- Further expand and build late stage CMC capabilities
- Responsible for late stage CMC project timelines and budgets
- Responsible for the overall management the late stage CMC activities with Genmab’s CMOs
- It is expected that you have a master’s degree in science, pharmacy or similar.
- You have at least 10 years of documented professional experience from CMC area and understand the interphase between development and commercial.
- It is also preferable if you have experience in developing and implementing complex strategies and working with an outsourced model.
- You have gained experience in leading teams in a biotechnology or pharma.
- 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, enjoy working leading a team and inspire others with your enthusiasm.
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 Recruiter Jannie Jensen, email@example.com
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To learn more about Genmab, you can visit our website: http://www.genmab.com/