• Job Description

  Req#: R8797

  At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off 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.

  Associate Director CMC, New Product Introduction

  Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.

  The Role

  Genmab is now looking for an Associate Director CMC, New Product Introduction, to join CMC Operations in Copenhagen.

  New Product Introduction (NPI) is part of CMC Operations in Copenhagen, which is now about 80 employees. CMC Operations is responsible for development and manufacture of Genmab drugs used in preclinical, clinical and commercial settings. The NPI team starts working on new Genmab Pipeline programs once the last candidates are tested for manufacturability and developability, carries out process, analytical or cell lines development and establishes the first GMP batches. Additionally, improvements required to support late-stage CMC activities are implemented in parallel with establishing clinical proof of concept. With the increasing complexity of antibody formats as e.g. bispecific or conjugated antibodies and Genmab propriety technologies as HexElect®, the challenges of fast and efficient CMC development are continuously renewed. At the same time, Genmab is increasing its pipeline throughput significantly and therefore a new Associate Director, CMC, New Product Introduction is required to support the strong growth and complexities during early-stage CMC Development.

  In your function as Team Lead New Product Introduction you will have the overall responsibility for a selected portfolio of Early-Stage CMC projects. Initially you will start with very few reports (1-2) and will be able to build and recruit your team during the year 2024. At least initially, prior to your team being fully recruited, you will also work as CMC PM on one of Genmab’s pipeline asset, which will allow you to understanding the internal project flows in your main role as line manager. As line manager for CMC PMs and CMC PM Associates you will guide your team through the different phases of CMC development from early candidate evaluation and cell line development through e.g. assay/process development and initial GMP manufacture. You will be overall responsible for the chosen CMC strategy and will adapt these strategies to the needs of each specific project and molecule. You will ensure that your team is able to reach the different project milestones in a timely manner, and compliant with relevant budget, quality and regulatory requirements. You will make sure that communication with internal and external stakeholders is of high standards. You will also represent the NPI team in different levels of internal and external governance to thrive the projects under your responsibility. You will report to Vice President CMC, Head of New Product Introduction.

  Responsibilities

  The responsibilities will include, but not be limited to:

  • Overall responsible for strategy and execution of CMC development towards CTA/IND and clinical proof of up to approx. 6 CMC Projects in the NPI CMC team
  • Line Manager for up to (eventually) 5-7 Project Managers/Project Manager Associates
  • Ensure and support employment and proper onboarding of new team members to support the growing pipeline
  • CMC PM for one pipeline program, at least during the initial team build-up phase
  • Collaborate with other Team Leads in the NPI team to ensure good resourcing of program and cross project/team alignment
  • Support development of appropriate and high-quality processes within CMC Operations.
  • Support batch forecasting together with the Supply Chain Team and ensure booking of development and GMP slots for your CMC programs
  • Represent the NPI team at different levels of internal and external governance
  • Reviewing regulatory CMC submissions
  • Ensure that your team and CMOs fulfill the requirements of the relevant quality systems and support your team on (critical) quality events as e.g. larger changes or major deviations
  • Help to improve and maintain CMC Operations’ and Genmab’s quality system
  • Ensure that your teams project budget is according to agreed project planning and internal governance

  Requirements

  • At least 8-10 years of working experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or therapeutic protein development and manufacture at clinical and/or commercial scale
  • You have a proven track record and the technical skills of biological process development and biopharmaceutical manufacturing
  • Extensive experience with CMC project management
  • Proficiency in GMP and CMC principles and industry practices as well thorough understanding of regulatory expectations and requirements within the biotech industry.
  • Fluency in English.
  • Prior experience as a people manager from a similar position and informal people management from positions within CMC project management is preferred; applicants with no prior experience as people manager and a strong desire to develop as people manager will be considered as this position is designed to allow the right applicant to grow with its tasks.
  • As Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture of investigational drugs, experience in running projects with external partners and governance of external manufacturing partners is required.

  Moreover, you meet the following personal requirements:

  • An entrepreneurial spirit combined with a positive, “go-do” attitude.
  • Ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals.
  • You have a flavor, intuition and interest for people management and understand to support your team member through times of high workload or challenging project situations.
  • An independent work-approach and good at building solid professional relations to

  collaborators and business partners.

  • You have a quality mindset
  • You are organized with a sense of details
  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab
  • You find it comfortable to work in an agile biotech environment
  • You are curious and like to challenge existing processes
  • You are proactive and open minded

  Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.

  At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.

  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.

  Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website: http://www.genmab.com/privacy/applicants-hr-genmab-a-s/

  Scam alert

  Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation. This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.

  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

  Locations

  Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

  About Genmab

  Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.

  When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.

  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. Learn more about our commitments on our website.

  Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website https://www.genmab.com/privacy .

• About the company

  Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund.

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