Senior Associate CMC for the Stability Team

2 months ago

København, Denmark Genmab Full time

At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department

Genmab´s clinical pipeline is in an exciting growth period, and we are looking for a Senior Associate to join the CMC Stability team in Denmark. This position will report to the Team Lead for the Stability team. This role is located in Copenhagen, Denmark and is hybrid.

You will be performing your work in close collaboration with your closest colleagues in the team, the CMC Project Manager, and the CMC Management team, where you will ensure that the stability activities are compliantly conducted and executed according to project timelines. This means that your stakeholders and activities are both internally in Genmab but also with CMOs and external collaborators.

Responsibilities

  • Handle stability studies in partnership with Genmab QC, CMC PMs, QA and with CMOs, i.e., handle the stability protocols, stability data, final stability reports, and non-compliances
  • Responsible for continuous oversight of the stability profile, including trending and setting of shelf life / expiry date
  • Responsible for oversight of stability testing activities performed at Genmab and at CMOs
  • Support authoring of regulatory stability sections (e.g., for both clinical and commercial product) and when needed, participate in response rounds with Health Authorities
  • Be part of improving how we operate within the team and with our stakeholders

Requirements

  • You hold a relevant scientific education on the level of master’s degree or related technical area.
  • A background working within the pharma/biotech industry
  • Knowledge and understanding of stability testing for products in clinical development and for marketed products

Moreover, you meet the following personal requirements:

  • Able to work successfully, with enthusiasm and integrity in a fast-paced environment with tight timelines
  • A team player with a demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support product development programs
  • You have a structured and systematic approach, flair for IT and user software to monitor stability.
  • Ability to manage multiple tasks, prioritize work

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

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. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Our commitment to diversity, equity, and inclusion
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.

Location: Copenhagen - Carl Jacobsens Vej 30

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