Senior CMC Specialist, Downstream Processing

Senior CMC Specialist, Downstream Processing

Genmab

Copenhagen, Denmark

The Role

As the (Senior) Downstream Processing (DSP) subject matter expert (SME), you will be responsible for DSP activities performed at Genmab’s partnered CMOs, and work across project teams to support the CMC Project Manager. You will also work closely with other SMEs, such as those in upstream processing, analytical validation, and characterization. With great energy, you will join Genmab’s growth journey and contribute with your downstream experience.

The position is an onsite role in Copenhagen and you will report to the Associate Director, Process Team Lead, Head of Late-Stage Manufacturing Development, CMC.

Responsibilities

• Late-stage development DSP strategies on ongoing projects;
• Defining the scope for the late-stage DSP development activities together with our CMOs and partners, according to the latest industry standards and regulatory guidance;
• Oversight of the DSP activities performed at partnered CMOs, such as troubleshooting, process characterization, and process performance qualification;
• Preparing/reviewing technical documents including development, tech transfer, and process characterization reports, and batch records;
• Authoring and reviewing CMC regulatory submission documents;
• Working closely with upstream processing 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, within Chemistry, Biochemistry, Pharmaceutical Sciences, or another relevant field, and has at least 5+ years of experience from the Downstream CMC area, preferably from Late-Stage Development;
• You have a thorough understanding and overview of downstream processes together with in-depth knowledge of downstream process characterization, risk assessment, and late-stage validation activities;
• Preferably you have experience designing and evaluating DoE experiments and virus clearance study design and evaluation;
• Experience in preparing and reviewing relevant filing documentation for regulatory market authorizations;
• You have a proactive mindset 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 under pressure in a fast-paced environment with tight timelines;
• As an open-minded, dedicated, and flexible person, you utilize your high level of energy and can-do attitude to proactively handle the various tasks at hand;
• Strong communication skills are essential in this role, which interacts with other disciplines, and you are, of course, excellent in English, both written and verbal;
• As an open-minded, dedicated, and flexible person, you utilize your high level of energy and can-do attitude to proactively handle the various tasks at hand;
• Strong communication skills are essential in this role, which interacts with other disciplines, and you are, of course, excellent in English, both written and verbal.

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!

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