- 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.
- Educate a broad audience including other functions and management on current appropriate technology for key applications.
- 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 ( SOPs, GxP, HSE, and AW)
- 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
- Scientific/technical expertise in dissolution particularly in the development and application of USP Apparatus II (Paddles) and IV (Flow Cell) are a plus.
- Successfully demonstrated track record of interactions with regulatory agencies ( FDA/ CVM, EMA)
- Extensive knowledge of current quality and regulatory requirements relevant for new drug products
- Experience working in regulated environments ( GMP)
- Experience in Analytical method development in areas of dissolution
- Proven scientific leadership skills
- Strong collaborator with the ability to positively impact in inter-disciplinary and international teams,
- Strong problem-solving skills including strategic and creative thinking.
- This position is located in Monheim am Rhein, Germany or Greenfield, US
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Subject Matter Expert Analytical Development, Small Molecule Technical Development - Monheim, Deutschland - Elanco
Beschreibung
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
The Subject Matter Expert Analytical Development directly supports Elanco's Technical Development (TD) organization and reports to a team leader of Analytical Development SMTD. This position is responsible for analytical development activities of animal health products and related activities associated with the development of animal health products. As part of technical development teams, the role is expected to support drug development with a diverse range of responsibilities. These responsibilities include analytical development activities from the pipeline entry to regulatory approval: Quality by design development and optimization of analytical methods including dissolution as well as validation and release analytics in compliance with industrial (GxP) and regulatory requirements (VICH/ICH) are focus areas of this role. In-depth scientific analytical expertise and communication skills are expected for partnering with manufacturing and regulatory representatives to successfully drive drug product commercialization activities and technical submissions to global health authorities. The Subject Matter Expert will take on responsibility of problem solving for questions related to analytics, cooperating within interdisciplinary and international teams and support ensuring launch readiness for analytical activities including transfer of methods to commercial organizations. This role will also be responsible for driving evaluation and implementation of new technologies in the field of analytics, applying the latest scientific thinking in analytical testing to help bring new drug products to market.
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.
The acceptable candidate should have relevant experience in authority interactions within technical sections of dossier submissions focusing on oral solid dosage forms and other formulation types suspensions.
Responsibilities will include but are not limited to:
Language requirement:
English
Basic Minimum Qualifications:
Additional Skills & Preferences:
Other information:
