Subject Matter Expert Analytical Development, Small - Monheim, Deutschland - Elanco

Elanco

Geprüftes Unternehmen

Monheim, Deutschland

vor 1 Woche

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Education :

EQUIVALENTEXPERIENCE

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. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet and our enterprise.

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

Responsibility for analytical control strategy, identification of future capability needs, support of identification and selection of Contract Research/Development/Manufacturing Organizations (CRO/CDMO) and technical oversight of CRO/CDMO development work are also crucial part of the role.

Responsibilities will include but are not limited to:

Develop and deliver relevant analytical methods including dissolution and specifications.
Interpret results, evaluate data and draw relevant conclusions.
Report and present scientific/technical results internally, may create external publications and patents and may present at scientific conferences or congresses.
Write or support the generation of international registration documents and interact with global health authorities
Work effectively and flexibly within and across Elanco R&D teams, manufacturing and external collaborators
Provide and accept challenge to deliver innovative technical solutions and create an innovative culture.
Mentor and coach emerging technical talent within the function.
Incorporate Quality by Design (QbD) principles throughout the development process in alignment with manufacturing commercialization.
Evaluate new scientific technologies, platforms and procedures. May participate in the evaluation of in licensing opportunities or due diligence.
Ensure the compliance with external and internal guidelines/quality standards (e.g. SOPs, GxP, HSE, and AW)

Language requirement:

English

Basic Minimum Qualifications:

Scientific degree (Pharmacy, pharmaceutical sciences or similar), PhD, plus min. 7 years of experience in pharmaceutical development (preferably analytics), ideally experience with various different dosage forms
Experience in chromatographic (HPLC/UPLC) and spectroscopic (UV/VIS) method development
Successfully demonstrated track record of interactions with regulatory agencies (e.g. FDA/ CVM, EMA)
Extensive knowledge of current quality and regulatory requirements relevant for new drug products

Additional Skills & Preferences:

Experience working in regulated environments (e.g. GMP)
Experience in Analytical method development in areas of dissolution
Proven scientific leadership skills
Strong collaborator with the ability to positively impact in interdisciplinary and international teams,
Strong problemsolving skills including strategic and creative thinking.

Other information:

This position is located in Monheim am Rhein, Germany or Greenfield, US

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