Senior Scientist Analytical Technology, Immedica

Immedica Pharma has experienced remarkable growth in recent years and is now strengthening their Manufacturing/CMC organization with an experienced analytical expert. The Manufacturing/CMC team is responsible for overseeing all aspects of the production of Immedicas’s products, all of which are manufactured externally. This includes defining CMC strategy, ensuring regulatory compliance, and coordinating activities with CLOs and CMOs.

As Senior Scientist Analytical Technology, you will play a key role in securing the quality, compliance, and lifecycle performance of analytical methods across Immedicas’s product portfolio. You will take the lead on analytical method transfers, validation activities, and continuous improvement initiatives, ensuring that our methods remain robust, efficient, and fit for purpose.

This is a new role created to gather all ASAT activities; hence it gives an exceptional opportunity for someone who wants to take lead and grow with the role. You will collaborate cross‑functionally and act as a central analytical resource supporting product quality, life cycle management projects such as manufacturing tech transfers, regulatory submissions, and ongoing development needs.

Since all laboratory work is conducted externally at CMOs and partner laboratories, success in this role requires strong collaboration skills, excellent communication, and the ability to build productive relationships with external partners.

Main responsibilities:

Act as analytical subject matter expert (SME) for Immedica’s products

Own and oversee analytical method performance, including trending of analytical release and stability data

Identify and drive improvements in analytical methods and control strategies

Coordinate stability studies, ensuring product stability and shelf life

Manage reference standards

Act as analytical SME in supporting investigations, changes, CAPAs and life cycle management activities

Act as analytical SME in regulatory submissions, inclu