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Open nowPosted 43 days ago

Sr. Scientist, CMC – mAb Manufacturing

Adcendo ApS

Where
Denmark
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Your applicationOpen nowSr. Scientist, CMC – mAb ManufacturingAdcendo ApS · Denmark

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This job: posted 43 days ago

The posting

Adcendo ApS is a clinical-stage biotechnology company headquartered in Copenhagen, Denmark. We are developing a pipeline of first-in-class antibody-drug conjugates (ADCs) targeting cancers with high unmet medical needs. Led by a team of industry veterans with a strong track record in advancing ADCs and biologics, Adcendo combines novel targets, optimized linker-payload technologies and a rational development strategy to bring next-generation cancer therapies to patients.

We are looking for a dedicated Sr. Scientist, CMC – mAb Manufacturing to join our CMC team. In this role, you will be responsible for developing the monoclonal antibody manufacturing process across our pipeline projects. You will work closely with internal stakeholders, CMC project management, QA and external CDMOs to ensure robust development, manufacturing and regulatory readiness of our mAb-based drug substance activities.

This position requires strong scientific and technical expertise within biopharmaceutical development and manufacturing, particularly monoclonal antibodies, as well as solid experience working with external manufacturing partners in a GMP-regulated environment.

The role

As Sr. Scientist, CMC – mAb Manufacturing at Adcendo, your responsibilities will include:

  • Development of mAb manufacturing process development across projects in collaboration with CMC PM and CDMO
  • Vendor selection, oversight and evaluation of CDMOs within mAb manufacturing
  • Coordination of scientific and technical work associated with mAb manufacturing within pipeline projects
  • Author and review appropriate CMC sections of IND and BLA submissions
  • Review of GMP/GDP out of specifications (OOS), deviations, change controls, complaints and distribution in collaboration with QA
  • Review of validation protocols, validation strategies, risk assessments such as FMEA
  • Review and approve mAb process development. manufacturing documentation and other technical reports to support regulatory filings
  • Review stability data and establish shelf life in collaboration with QA

Qualifications and experience

Our ideal candidate has solid experience from a similar role within biopharmaceutical development and manufacturing. You have a strong understanding of CMC development in a biotech or pharma setting and are comfortable working in a dynamic environment with multiple projects, external partners and stakeholders across geographies.

You bring both scientific depth and a pragmatic, collaborative mindset, enabling you to make sound decisions while maintaining high quality and attention to detail.

We expect that you have:

  • Relevant academic background in sciences as a Pharmacist, Biochemist, Chemist or Engineer and experience with development of biopharmaceutical products
  • At least 5 – 10 years relevant industry experience
  • Working in a GMP environment and have experience in pharmaceutical development e.g. manufacturing or analytical development and project management.
  • Deep experience within development and manufacturing of monoclonal antibodies, establishment of cell banks, upstream and downstream processing.
  • Experience within tech transfer of manufacturing processes
  • Experience within lates stage development, process validation and BLA filings
  • Management of external relationships and outsourced contract manufacturing organizations
  • Excellent collaboration skills

As a person, you are structured, quality-focused and proactive. You thrive in a growing biotech company where priorities may evolve, and you are motivated by contributing to the development of innovative therapies for patients with high unmet medical needs.

Other details

  • The position is full-time and comes with the expectation of significant on-site presence at our Copenhagen offices
  • Approximately 10–20 travel days per year are expected
  • The Sr. Scientist, CMC – mAb Manufacturing reports to the Executive Director, CMC Project Management

Working at Adcendo

At Adcendo, we are on a mission to develop breakthrough antibody-drug conjugate therapies for cancers with high unmet medical needs. Our work is guided by a patient-centric, science-driven approach and powered by a passionate team committed to quality, performance and innovation.

We believe great science happens in a culture of collaboration, respect and transparency. At Adcendo, you will find cross-functional teamwork, opportunities to grow and the balance needed to thrive both personally and professionally.

How to apply

If you thrive in an international environment and have strong experience with mAb manufacturing from Pharma or Biotech, we encourage you to apply and join us at this exciting time for Adcendo.

To apply, please submit your CV including a short motivation for applying for the job. If you have any questions regarding this position, please send them to [email protected]. Please read about Data Privacy for job applicants on our website: www.adcendo.com.

Interviews will be conducted on an ongoing basis, and the position will be filled as soon as a suitable candidate is identified.

Join us in shaping an emerging biotech company and the future of cancer treatment.

Adcendo – Designed for Precision. Developed for Life.

Posting text belongs to the employer. Removal requests: contact us.

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