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For our client, a leading global pharmaceutical company, we are looking for a Technical R&D – Analytical Project Lead (m/f/d) to join their team as soon as possible or by 1 March 2027 at the latest.
This is a 100% position, offered on a 12-month fixed-term contract.
Description du poste
- Act as the Analytical Subject Matter Expert (SME) and Analytical Project Lead (APL), driving the development of advanced analytical control strategies for synthetic molecules, particularly peptides.
- Develop and implement robust analytical control packages for raw materials, in-process controls (IPCs), intermediates and crude APIs.
- Contribute to process development and portfolio delivery by applying innovative analytical techniques, including modelling and simulation.
- Provide technical guidance and coaching to technicians and junior scientists, acting as a key point of contact for project-related matters.
- Oversee internal laboratory activities as well as analytical testing performed by external Contract Development and Manufacturing Organisations (CDMOs) and Contract Laboratories (CLOs).
- Lead external analytical testing activities in the role of Chemistry Project Lead (CPL).
- Collaborate closely with cross-functional teams across Research, Early Development, Regulatory Affairs and Quality to ensure successful project execution.
- Author, review and approve technical documentation and regulatory dossiers, including QIMPDs and NDAs, ensuring compliance with quality standards and data integrity requirements.
Profil attendu
- Master's degree or PhD in Chemistry, Pharmacy or a related scientific discipline.
- At least 5 years of professional experience in analytical development of synthetic drug substances, with a strong focus on peptides.
- Extensive expertise in liquid chromatography techniques, particularly HPLC and UHPLC.
- Practical experience with different analytical detection techniques, including UV, mass spectrometry (MS), fluorescence and charged aerosol detection (CAD).
- Strong knowledge of analytical chemistry, including chromatographic techniques (HPLC, GC), titrations and physicochemical methods.
- Proven ability to independently drive analytical development projects and establish analytical control strategies.
- Excellent communication, collaboration and technical leadership skills, including experience in coaching and supervising junior colleagues.
- Experience in project management and coordination of external CDMOs and CLOs.
- Familiarity with statistical analysis of analytical data and a strong interest in digital transformation.
- Experience in authoring and reviewing regulatory documentation and dossiers.
- Excellent command of English, both written and spoken.
Nice-to-Haves:
- Good command of German is considered an advantage.
If you are passionate about analytical development and would like to contribute to the development of innovative pharmaceutical therapies, we look forward to receiving your application!
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