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Senior Downstream Processing Specialist

2 months ago

Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our team is passionate about our purpose and genuinely cares about our mission to transform the lives of patients through innovative cancer treatment.

We're looking for a skilled Downstream Processing Specialist to join our experienced Late-Stage Development team, working on late-phase development activities of portfolio projects and preparing the CMC package for regulatory filings in a stimulating international environment. As a key member of our team, you will be responsible for developing late-stage DSP strategies for ongoing projects, defining the scope for late-stage DSP development activities with our CMOs and partners, and overseeing DSP activities performed at partnered CMOs.

Key Responsibilities

  • Developing late-stage DSP strategies for ongoing projects
  • Defining the scope for late-stage DSP development activities with our CMOs and partners
  • 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

Requirements

  • A degree in Life Science, such as Chemistry, Biochemistry, Pharmaceutical Sciences, or another relevant field
  • At least 5+ years of experience in the Downstream CMC area, preferably from Late-Stage Development
  • Thorough understanding and overview of downstream processes, with in-depth knowledge of downstream process characterization, risk assessment, and late-stage validation activities

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. Our team is passionate about our purpose and genuinely cares about our mission to transform the lives of patients through innovative cancer treatment.

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.