Responsibilities:
This role is broadly responsible for leading the analytical development activities for veterinary medicinal products, with concentrated expertise in dissolution development and control strategy.
Your key responsibilities include:
1. Represent Analytical Development & QC in international technical development project teams
2. Developing and delivering relevant analytical methods, setting specifications, and ensuring compliance with industrial (GxP) and regulatory requirements (VICH/ICH).
3. Applying Quality by Design principles for method development, optimization, and validation.
4. Conducting analytical tests, stability studies, and preparing analytical registration documentation for worldwide registration.
5. Interpreting results, evaluating data, and drawing relevant conclusions, then reporting and presenting scientific/technical results internally and externally.
6. Driving the evaluation and implementation of new technologies in dissolution and analytical development.
7. Mentoring technical staff and ensuring compliance with internal and external quality standards (, SOPs, GxP, HSE, AW).
What You Bring (preferred qualifications):
Education:
8. Completed university degree with a doctorate, preferably in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field.
Technical Expertise:
9. Profound knowledge in pharmaceutical analytics and techniques.
10. Strong expertise in chromatographic (HPLC/UPLC) and spectroscopic (UV/VIS) method development, particularly dissolution with USP Apparatus II (Paddles) and IV (Flow Cell).
11. Extensive knowledge of current quality and regulatory requirements for new drug products.
12. Demonstrated track record of interactions with regulatory agencies (, FDA/CVM, EMA) on analytical topics.
13. Experience in regulated environments (GMP/GLP) is an advantage.
Professional Skills:
14. Proven scientific leadership skills and strong collaboration abilities for interdisciplinary and international teams.
15. Excellent cross-functional communication and strong problem-solving skills.
16. High degree of initiative, commitment, and teamwork.
17. Very good written and spoken English and German skills.
What we offer
18. Employer subsidised pension scheme
19. 40 hours / week
20. 30 days holiday + opportunity to earn more time off
21. Active BGM and health care
22. Subsidy for the Deutschlandticket and bicycle leasing
23. Meal allowance in the canteens
24. Scope for personal initiative and opportunities for individual further training
25. Work in a dynamic team in an international company