Senior CMC Specialist, Downstream Processing

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role

Do you want to work as one team? Share knowledge, be curious, ask questions, and learn new things to achieve goals and meet ambitious deadlines? You will be rewarded by focusing on teamwork and achieving outstanding results through and with your team. Genmab is a growing organization, and you will be encouraged and welcomed to bring forth new ideas, discuss concerns, and share feedback with colleagues and management.

You will be part of the experienced Late-Stage Development (LSMD) team, working on late-phase development activities of portfolio projects and preparing the CMC package for regulatory filings in a stimulating international environment. If you can recognize yourself in this description, you might be the next brilliant Senior CMC Specialist, Downstream Processing, to support Genmab`s expanding portfolio and continued global growth.

You will report to the Associate Director, BI/DS Process Team Lead, Head of Late-Stage Manufacturing Development, CMC. The Process team responsible for Upstream and Downstream processes, currently consisting of 10 people and expanding.

This position is based in our Copenhagen Headquarters Office, Denmark  and is hybrid, with onsite presence 60% of the time.

We consider applications as they arrive.

Responsibilities

With great energy, you will join Genmab’s growth journey and contribute with your downstream experiences. 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 passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer tr