Analytical Laboratory Head
Vor 5 Tagen
At Elanco (NYSE: ELAN) – it all starts with animals
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.
At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better – join our team today
Laboratory Head (m/f/d) Analytical Development & QC, Small Molecule Technical Development (SMTD)
We are looking for a Laboratory Head Analytical Development & QC, SMTD (m/f/d) to join us as soon as possible at our Monheim am Rhein, Germany location.
This job is a 1-year fixed duration position.
Your 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:
- Represent Analytical Development & QC in international technical development project teams
- Developing and delivering relevant analytical methods, setting specifications, and ensuring compliance with industrial (GxP) and regulatory requirements (VICH/ICH).
- Applying Quality by Design principles for method development, optimization, and validation.
- Conducting analytical tests, stability studies, and preparing analytical registration documentation for worldwide registration.
- Interpreting results, evaluating data, and drawing relevant conclusions, then reporting and presenting scientific/technical results internally and externally.
- Driving the evaluation and implementation of new technologies in dissolution and analytical development.
- Mentoring technical staff and ensuring compliance with internal and external quality standards (e.g., SOPs, GxP, HSE, AW).
What You Bring (preferred qualifications):
Education:
- Completed university degree with a doctorate, preferably in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field.
Technical Expertise:
- Profound knowledge in pharmaceutical analytics and techniques.
- Strong expertise in chromatographic (HPLC/UPLC) and spectroscopic (UV/VIS) method development, particularly dissolution with USP Apparatus II (Paddles) and IV (Flow Cell).
- Extensive knowledge of current quality and regulatory requirements for new drug products.
- Demonstrated track record of interactions with regulatory agencies (e.g., FDA/CVM, EMA) on analytical topics.
- Experience in regulated environments (GMP/GLP) is an advantage.
Professional Skills:
- Proven scientific leadership skills and strong collaboration abilities for interdisciplinary and international teams.
- Excellent cross-functional communication and strong problem-solving skills.
- High degree of initiative, commitment, and teamwork.
- Very good written and spoken English and German skills.
What We Offer
- Employer subsidised pension scheme
- 40 hours / week
- 30 days holiday + opportunity to earn more time off
- Active BGM and health care
- Subsidy for the Deutschlandticket and bicycle leasing
- Meal allowance in the canteens
- Scope for personal initiative and opportunities for individual further training
- Work in a dynamic team in an international company
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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