Senior CMC Specialist, Upstream Processing

Senior CMC Specialist, Upstream Processing

Genmab

Copenhagen, Denmark

The Role & Department

Do you want to join our highly talented Late-Stage Manufacturing Development (LSMD) Subject Matter Expert (SME) team within CMC Operations and work closely with late-phase development activities in a stimulating international environment?

With Genmab’s continued growth, we work with strong engagement to prepare high-quality CMC packages for regulatory filings. We are now looking for a Senior CMC Specialist, Upstream Processing, to join our journey and contribute with strong upstream expertise.

You will be part of Late-Stage Manufacturing Development (LSMD), contributing to late-phase development activities across portfolio projects and preparing CMC packages for regulatory filings. The position is placed in the USP 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 Head of late-stage Process Development.

Responsibilities

As the Senior CMC Specialist, Upstream Processing (USP) Subject Matter Expert (SME), you will be responsible for upstream activities performed at Genmab’s partnered CMOs and work across project teams to support the CMC Project Managers. Your responsibilities include:

• Developing and maintaining late-stage upstream processing strategies, including support to lifecycle management of marketed and late-stage assets;
• Defining the scope of late-stage upstream development activities with CMOs and partners in line with current industry standards and regulatory guidance;
• Overseeing upstream activities performed at partnered CMOs, including troubleshooting, process characterization, and process performance qualification;
• Preparing and reviewing technical documentation, including development, tech transfer, and process characterization reports, batch records, and SOPs;
• Authoring and reviewing CMC documentation for regulatory submissions;
• Working closely with downstream processing, analytical validation, and characterization SMEs to align late-stage development strategies;
• Supporting the definition, implementation, and continuous improvement of processes related to upstream activities.

Requirements

• Master’s in Natural Sciences, Pharmacy or related field;
• 5-10 years of professional experience with the upstream CMC area, preferably from late-stage development;
• Strong understanding and overview of mammalian upstream processes, with in-depth knowledge of process characterization, risk assessment, and late-stage validation activities;
• Experience preparing and reviewing documentation for regulatory market authorizations;
• Preferred experience designing and evaluating DoE studies;
• 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!