Senior CMC Specialist, Downstream Processing, Lifecycle Management

Senior CMC Specialist, Downstream Processing, Lifecycle Management

Genmab

Copenhagen, Denmark

Responsibilities

With strong drive and engagement, you will join Genmab’s growth journey and contribute with your downstream experience in a lifecycle management context. As the (Senior) Downstream Processing (DSP) subject matter expert (SME) for lifecycle management, you will be responsible for the following:

• DSP activities performed at Genmab’s partnered CMOs and work across project teams to support the CMC Project Manager
• Developing late-stage DSP and DS strategies for ongoing projects
• Act as the primary expert for managing the lifecycle of late-stage biopharmaceutical products, ensuring alignment with regulatory requirements and company standards
• Defining the scope for late-stage DSP and DS development activities with our CMOs and partners according to the latest industry standards and regulatory guidance
• Overseeing DSP and DS activities performed at partnered CMOs, including troubleshooting, process characterization, and process performance qualification
• Preparing and reviewing technical documents, including development/tech transfer/process characterization reports and batch records
• Authoring and reviewing CMC regulatory submission documents
• Working closely with upstream processing, analytical validation, and characterization SMEs to develop and align late-stage development strategies
• Supporting the definition and refinement of required processes for DSP activities

Requirements

The ideal candidate holds a degree in Life Science, such as Chemistry, Biochemistry, Pharmaceutical Sciences, or another relevant field, and has at least 7+ years of experience in the Downstream CMC area, preferably from Late-Stage Development.

The successful candidate will have the following profile:

• Thorough understanding and overview of downstream processes, with in-depth knowledge of downstream process characterization, risk assessment, and late-stage validation activities
• Experience in leading lifecycle management activities, including process optimization, process comparability, and global post-approval changes
• Preferred experience in antibody drug conjugates (ADCs)
• Preferred experience in designing and evaluating DoE experiments
• Preferred experience with virus clearance study design and evaluation
• Preferred experience in preparing and reviewing relevant filing documentation for regulatory market authorizations

Moreover, you meet the following personal requirements:

• You are focused on achieving goals that are important for the team and the organization
• You have a proactive approach and a desire to continuously develop and find innovative solutions
• In addition, you are well-organized, and can plan, execute, and meet deadlines
• You have the ability to work successfully in a fast-paced environment and with tight timelines

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!