As a Senior Scientist, CMC Fill & Finish, you will join the Drug Product Development team within CMC – Product Development (CMC-PD). In this newly created role, you will play a key part in establishing Genmab's internal Fill & Finish capabilities, supporting the development of antibody therapeutics from early-stage development through to commercialization.
This is an exciting opportunity to build something new. You will establish and lead a non-GMP Fill & Finish laboratory while building and mentoring a team of Research Analysts. Working closely with colleagues across CMC, Technical Development, Project Management and external partners, you will help shape robust Fill & Finish strategies, introduce new technologies and automation, and deliver high-quality scientific data that enables critical development decisions.
While you will have the opportunity to lead and build new capabilities, you won't be doing it alone. You will join a collaborative, down-to-earth team that enjoys solving scientific challenges together and values openness, knowledge sharing and supporting one another. We believe the best ideas come from working together, challenging each other constructively and celebrating successes as a team. As priorities evolve throughout drug development, we're looking for someone who enjoys bringing structure to a dynamic environment, is energized by building new capabilities, and is excited to help shape both the science and the team around it.
Responsibilities
Build, lead and develop Genmab's non-GMP Fill & Finish laboratory and associated capabilities.
Recruit, mentor and manage a team of 4-6 Research Analysts, fostering scientific growth, collaboration and accountability.
Act as the Fill & Finish representative within cross-functional CMC project teams, collaborating closely with colleagues across multiple functions and external partners.
Define and execute Fill & Finish development strategies that support project progression and reduce technical risk.
Plan, prioritize and oversee laboratory activities, ensuring high scientific quality and timely delivery.
Drive laboratory automation and implement new technologies that improve efficiency and scientific capabilities.
Design, review and interpret experimental studies, integrating historical and platform knowledge to support data-driven decision making.
Prepare study protocols, technical reports and documentation supporting product development and regulatory submissions.
Present scientific results and recommendations to project teams and key stakeholders.
Continuously identify opportunities to optimize laboratory workflows, processes and ways of working.
Collaborate closely with the Formulation Development team and other CMC functions to continuously improve Fill & Finish and stability workflows.
Requirements
PhD in Biochemical Engineering, Bioengineering, Pharmaceutical Sciences, Process Development or another relevant scientific discipline, or equivalent industry experience.
At least 5 years of relevant experience in Fill & Finish development, drug product development, process development, laboratory automation or a closely related field.
Strong understanding of protein biochemistry and analytical techniques supporting Fill & Finish and container closure development.
Hands-on experience with analytical techniques such as Absorbance Spectroscopy, CE-SDS, icIEF, HPLC, Bio-Layer Interferometry (BLI), DLS/DSF and Micro-Flow Imaging (MFI).
Experience with laboratory automation is highly desirable.
Experience interpreting scientific data and applying statistical or trend analyses to support decision making is an advantage.
Previous people management experience is beneficial but not essential. Experience coaching or mentoring colleagues is equally valued.
Strong organizational skills with the ability to manage multiple priorities in a dynamic development environment.
Excellent communication and stakeholder management skills, with the ability to collaborate across functions and external partners.
Fluent written and spoken English, our main language.
Don't forget to mention EuroPharmaJobs when applying.