Senior CMC Specialist, Downstream Processing

Senior CMC Specialist, Downstream Processing

Genmab

Copenhagen, Denmark

Responsibilities

With great energy, you will join Genmab’s growth journey and contribute with your downstream experiences.

As the (Senior) Downstream Processing (DSP) subject matter expert (SME), 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 strategies for ongoing projects
• Defining the scope for late-stage DSP development activities with our CMOs and partners according to the latest industry standards and regulatory guidance
• Overseeing DSP 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 5+ 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
• 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 treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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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Denmark      Clinical Research      Manufacturing and Logistics      On-site      Genmab