Tasks

• Technical and disciplinary management/group leadership of an analytical project team of experienced chemical laboratory technicians, including supervision of trainees.
• Pharmaceutical development of transdermal therapeutic systems in accordance with applicable guidelines and within the deadlines specified in the project plan.
• Development of analytical methods for raw materials and pharmaceutical preparations
• Supervision and implementation/coordination of analytical method development and validation, taking into account the internal QM system.
• Ensuring the ongoing and transparent documentation of development data/project work, including approval of raw data and literature research.
• Creation or review, including evaluation, approval and training of documents for analytical method validation and revision (e.g., validation plans, evaluations, validation reports, troubleshooting) within the Transdermal Development department, in compliance with the relevant guidelines, in particular ICH Q2; analogously for method transfers
• Creating or reviewing internal and external reports (e.g., development reports, validation plans and reports, etc.) as well as other GMP-relevant documents such as SOPs, work instructions, and test procedures.
• Preparation of admission applications for Module 3 and IMPD/IND, as well as processing of deficiency notices.
• Support for analytical calculation sheets and their validation
• Administration of software, e.g. Chromeleon and Validat in the department
• Possibly practical work in drug testing (qualitative and quantitative)
• Presentation of projects internally and externally
• Chemicals management, creation and review/revision of hazard assessments for the analytical area
• Release of analytical equipment on behalf of the Manager of Analytical Services for the department

Requirements

• Natural scientist (m/f/d) preferably with a doctorate and/or several years of professional experience in the field of chemistry or pharmacy (analytical development or quality control)
• Solid knowledge of instrumental analysis, especially HPLC, GPC and GC 
• At least 2 years of experience in analytical method development and validation
• Basic knowledge of pharmaceutical legislation and regulations, especially GMP
• Very good German (min. C1) and good English skills (min. B2) in spoken and written form
• Reliable, conscientious, proactive and independent/reflective work style with leadership skills