Principal Scientist

vor 2 Monaten

Monheim, Deutschland Elanco Vollzeit

Responsibilities:

 

Develop and deliver relevant analytical and dissolution methods and specifications, ensuring compliance with industrial (GxP) and regulatory requirements (VICH/ICH). 

Interpret results, evaluate data, and draw relevant conclusions. 

Report and present scientific/technical results internally, create external publications, and present at scientific conferences. 

Write or support the generation of international registration documents and interact with global health authorities. 

Partner with manufacturing and regulatory representatives to drive drug product commercialization activities and technical submissions to global health authorities. 

Drive the evaluation and implementation of new technologies in dissolution and analytical development, applying the latest scientific thinking to help bring new drug products to market. 

Mentor and coach emerging technical talent within the function. 

Ensure compliance with external and internal guidelines/quality standards (, SOPs, GxP, HSE, and AW). 

What You Need to Succeed (minimum qualifications): 

Education: PhD in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field, with a minimum of 7 years of experience in pharmaceutical development (preferably analytics), ideally with experience in various dosage forms. in related field with a minimum of 12 years of experience in the pharmaceutical industry, or in related field with a minimum of 16 years of experience in the pharmaceutical industry. 

Experience: Strong expertise in chromatographic (HPLC/UPLC) and spectroscopic (UV/VIS) method development, and recognized expertise in dissolution particularly with USP Apparatus II (Paddles) and IV (Flow Cell). 

Top 2 skills: 

Extensive knowledge of current quality and regulatory requirements for new drug products. 

Demonstrated track record of interactions with regulatory agencies (, FDA/CVM, EMA) analytical topics. 

What will give you a competitive edge (preferred qualifications): 

Strong dissolution development experience and submitting to agencies 

Experience working in regulated environments (, GMP). 

Proven scientific leadership skills. 

Strong collaborator with the ability to positively impact interdisciplinary and international teams. 

Strong problem-solving skills, including strategic and creative thinking. 

Experience in analytical method development in areas outside of dissolution. 

Additional Information: 

Travel: Approximately 10% travel required. 

Location: Monheim, Germany

WHAT WE OFFER

Freedom for personal initiative and opportunities for individual further training

Work in a dynamic team

Subsidization of pension provision by the employer

30 days’ vacation

Health and fitness offerings in an international company

Subsidized Job Ticket and bike leasing

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