(Senior) Specialist, CMC Downstream Processing, Lifecycle Management

(Senior) Specialist, CMC Downstream Processing, Lifecycle Management

Genmab

Copenhagen, Denmark

The Role

Do you want to join a highly skilled Lifecycle Management (LCM), Subject Matter Expert (SME), team within MSAT CMC Operations and work closely with commercial and late stage activities in a stimulating international environment?

With strong drive and engagement, you will join Genmab’s growth journey and contribute with your downstream processing experience in a lifecycle management context. As the (Senior) DSP SME, for Lifecycle Management, you will be responsible for downstream activities performed at Genmab’s partnered CMOs and work across project teams to support the CMC Project Managers.

You will be part of Process Development in MSAT. Process Development is responsible for upstream, downstream, and drug linker processes, and works closely with CMC Project Managers, CMOs, and cross functional SMEs to support late-stage development, commercial manufacturing, and lifecycle management activities. The function currently consists of 15 people and is expanding. You will report to the Associate Director, Team Lead CMC Downstream Processing.

Key Responsibilities

• Developing and maintaining late stage and commercial downstream processing strategies, with a clear focus on lifecycle management of marketed and late-stage assets
• Acting as the downstream processing SME for lifecycle management activities, batch review, process comparability, continued process verification, and global post approval changes
• Evaluation of process performance, manufacturing trends, deviations, and change controls related to downstream processing
• Defining the scope of downstream development and lifecycle management activities with CMOs and partners in line with current industry standards, regulatory expectations, and project needs
• Overseeing downstream activities performed at partnered CMOs, including troubleshooting and commercial process support
• Authoring and reviewing CMC regulatory submission documents, responses to health authority questions, and documentation supporting post approval changes
• Working closely with upstream processing, analytical validation, characterization, quality, regulatory CMC, and manufacturing SMEs to align late stage and lifecycle management strategies
• Supporting the definition, implementation, and continuous improvement of internal processes related to downstream lifecycle management activities

Requirements

• Holds a degree in Life Science, such as Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or another relevant fields
• For the CMC Specialist level, the ideal candidate has at least 3 years of documented professional experience within downstream CMC, preferably from late-stage development, commercial manufacturing support, or lifecycle management
• For the Senior CMC Specialist level, the ideal candidate has at least 7 years of documented professional experience within downstream CMC, preferably with significant experience from late-stage development, commercial manufacturing support, lifecycle management, or regulatory CMC activities.
• The successful candidate will have the following profile:
• Strong understanding of mammalian downstream processes, including chromatography, TFF operations, virus clearance, process parameters, raw materials, scale up, and process control strategies
• Knowledge of downstream process characterization, risk assessment, process validation, process performance qualification, and continued process verification
• Experience with lifecycle management activities, including process optimization, process comparability, process monitoring, deviation support, change control, and post approval changes
• Experience preparing and reviewing CMC documentation for regulatory submissions and market authorizations
• Preferred experience working with CMOs and external partners in a late stage or commercial manufacturing setting
• Strong written and oral communication skills in English

About You

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!