Senior CMC Specialist, Downstream Processing, Lifecycle Management

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

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.

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.

You will be part of Late-Stage Manufacturing Development (LSMD), contributing to late-phase development with a clear focus on lifecycle management activities across portfolio projects and preparing CMC packages for regulatory filings in a stimulating international environment. If you can recognize yourself in this description, you might be the next (Senior) CMC Specialist, Downstream Processing, Lifecycle Management, supporting Genmab’s expanding portfolio and continued global growth.

The position is placed in the DSP/DS team within Process Development. Process Development is part of LSMD and is responsible for Upstream, Downstream, and drug linker processes. The function currently consists of 13 people and is expanding. You will report to the DSP/DS Team Lead within Process Development.

The position is based in Copenhagen, Denmark.
Applications are reviewed on an ongoing basis.

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 r