Senior CMC Development Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

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.



  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior Vendor Specialist, CMC Development QALundbeck is seeking an experienced Senior Vendor Specialist to lead the CMC Development QA vendor management program. As a key member of the QA team, you will be responsible for ensuring the compliance and quality of our vendors, supporting the development of new innovative treatments for brain diseases, and...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior Vendor Specialist, CMC Development QAAs a key member of our CMC Development QA team, you will play a crucial role in driving the continuous development of our vendor management program. This includes training colleagues, ensuring compliant vendor oversight of our CMOs for clinical trials, and supporting our current pipeline from early stage to late...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior QA Specialist for CMC DevelopmentThis is a unique opportunity to lead the QA of the Lundbeck CMC vendor management program while contributing to the development of innovative treatments for brain diseases.We offer an exciting job with a broad variety in your daily work ensuring compliant vendor oversight of Lundbeck CMOs for clinical trials. CMC...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior Vendor Specialist, CMC Development QALundbeck is seeking a highly skilled Senior Vendor Specialist to lead the CMC vendor management program. As the QA lead, you will drive the continuous development of the program, including training of colleagues, and ensure compliant vendor oversight of Lundbeck CMOs for clinical trials.Key ResponsibilitiesQA owner...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior Vendor Specialist, CMC Development QA ProfessionalWe are seeking an experienced Senior Vendor Specialist to join our CMC Development QA team. As a Senior Vendor Specialist, you will be responsible for ensuring the quality and compliance of our vendors, driving the continuous development of our vendor management program, and leading audits and vendor...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior Vendor Specialist, CMC Development QAThis is an excellent opportunity to lead the QA of Lundbeck's CMC vendor management program while contributing to the development of innovative treatments for brain diseases. As a key program owner, you will drive the continuous development of the vendor management program, including training colleagues.We offer a...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Role OverviewWe are seeking a skilled Senior Vendor Specialist to join our CMC Development team as a QA lead for the vendor management program. This is a great opportunity to contribute to the development of new innovative treatments for brain diseases while driving the continuous improvement of our vendor management program.About the JobAs a Senior Vendor...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Lundbeck is a global leader in the development and manufacturing of innovative treatments for brain diseases.As Senior Vendor Expert, CMC Development Oversight Specialist, you will play a key role in our vendor management program, ensuring compliance and quality assurance for our clinical trials.The ideal candidate holds a master's degree in pharmacy,...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    About LundbeckLundbeck is a global pharmaceutical company with a rich history of developing innovative treatments for brain diseases. Our mission is to bring life-changing therapies to patients in need.Job OverviewWe are seeking a highly skilled Senior Vendor Specialist to join our CMC Development QA team. This is an exciting opportunity to work on the...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    At Lundbeck, we are seeking an experienced QA Specialist to lead our vendor management program in CMC Development. As a key member of our team, you will play a crucial role in ensuring compliant vendor oversight of our Contract Manufacturing Organizations (CMOs) for clinical trials.We offer an exciting opportunity to work with a broad range of tasks,...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior QP Delegate, CMC Development QA SpecialistThis is a unique opportunity to contribute to the development of innovative treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck ́s clinical trials. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Lundbeck is a global leader in the development and production of innovative treatments for brain diseases.We are seeking an experienced Senior QA Vendor Specialist to join our CMC Development team in Copenhagen.This is a fantastic opportunity to work with a talented team of professionals who are passionate about making a difference in the lives of people...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    GMP/GDP Auditor, CMC Development QA SpecialistThis is an exciting opportunity to join our team as a GMP/GDP auditor in CMC Development QA, supporting the development of new innovative treatments for brain diseases. You will have a key role as lead auditor conducting external audits of CMC vendors as well as internal audits of CMC. We offer a challenging job,...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior QP Delegate, CMC Development QAThis is a unique opportunity to contribute to the development of innovative treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck ́s clinical trials. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your professional...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior QP Delegate, CMC Development QAThis is a great opportunity to contribute to the development of new innovative treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck ́s clinical trials. You will leverage your professional and personal competencies to drive the continuous improvement of the...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    GMP/GDP Auditor, CMC Development and Quality Assurance Specialist This is an exciting opportunity for an international position as a GMP/GDP auditor in CMC Development and Quality Assurance, supporting the development of new innovative treatments for brain diseases. In this role, you will have a vital part as a lead auditor conducting external audits of...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior QP Delegate, CMC Development QA RoleThis is an exciting opportunity to contribute to the development of innovative treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck ́s clinical trials. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a Senior CMC Project Manager to join the Late-stage Manufacturing Development (LSMD) Team in Copenhagen.The LSMD CMC Team is part of CMC Operations in Copenhagen, which has a team of close to employees. CMC Operations is responsible for development and manufacture of Genmab antibody drugs used in preclinical, clinical, and...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    GMP/GDP Auditor, CMC Development QAThis is an exciting opportunity for a professional to join our team as a GMP/GDP auditor in CMC Development QA, supporting the development of new innovative treatments for brain diseases. As a lead auditor, you will have an important role in conducting external audits of CMC's vendors as well as internal audits of CMC.Your...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Quality Assurance Specialist, CMCLeverage your expertise in quality assurance to support the development of new treatments for brain diseases at Lundbeck. As a Quality Assurance Specialist, CMC, you will ensure patient safety and GMP compliance of Investigational Medicinal Products (IMPs) for clinical trials.Your Key ResponsibilitiesReview batch records to...