Senior CMC Development Specialist
2 weeks ago
About Genmab's Late-Stage Development Team
We are seeking a skilled Senior CMC Specialist, Downstream Processing, to join our experienced Late-Stage Development team. As a key member of this team, you will be responsible for developing late-stage DSP strategies for ongoing projects, defining the scope for late-stage DSP development activities, and overseeing DSP activities performed at partnered CMOs.
Key Responsibilities
- Develop and implement late-stage DSP strategies for ongoing projects
- Define the scope for late-stage DSP development activities with our CMOs and partners
- Oversee DSP activities performed at partnered CMOs, including troubleshooting, process characterization, and process performance qualification
- Prepare and review technical documents, including development/tech transfer/process characterization reports and batch records
- Author and review CMC regulatory submission documents
- Collaborate with upstream processing, analytical validation, and characterization SMEs to develop and align late-stage development strategies
Requirements
- Master's or Ph.D. in a relevant field, such as Chemistry, Biochemistry, or Pharmaceutical Sciences
- At least 5+ years of experience in the Downstream CMC area, preferably from Late-Stage Development
- Expertise in downstream process characterization, risk assessment, and late-stage validation activities
- Experience in designing and evaluating DoE experiments, virus clearance study design and evaluation, and preparation and review of regulatory filing documentation
About Genmab
Genmab is a global biotechnology company committed to transforming the lives of patients through innovative and differentiated antibody therapeutics. With a strong focus on translational research and data sciences, we have developed a pipeline of next-generation antibody technology platforms and innovative therapies.
Why Join Genmab?
- Collaborate with a talented and experienced team of professionals
- Contribute to the development of innovative therapies that transform patient lives
- Enjoy a dynamic and fast-paced work environment with opportunities for growth and development
Contact Information
Please submit your application by expressing your interest in the role and attaching your resume and cover letter. We look forward to hearing from you.
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