Dissolution Expert Analytical Development, Small Molecule Technical Development (SMTD) (m/f/d)

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
The Dissolution Expert Analytical Development directly supports Elanco’s Technical Development (TD) organization and reports to the Head of Analytical Development SMTD. This position is broadly responsible for analytical development activities of animal health products with a concentrated expertise in dissolution control strategy. 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 dissolutions methods 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 dissolution 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 Dissolution Expert will take on responsibility of problem solving for questions related to dissolution, 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 dissolution, applying the latest scientific thinking in dissolution testing to help bring new drug products to market.
Responsibility for dissolution 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 dissolution of orals solid dosage forms and other formulation types e.g. suspensions.
Responsibilities will include but are not limited to:

• Develop and deliver relevant dissolution methods 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.
• As recognized dissolution expert across the R&D function, 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 (e.g. SOPs, GxP, HSE)
  

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
• Recognized scientific/technical expertise in dissolution particularly in the development and application of USP Apparatus II (Paddles) and IV (Flow Cell).
• Strong expertise on solubility, dissolution, permeability, pharmacokinetics, as well as bioequivalence aspects of drug development
• Successfully demonstrated track record of interactions with regulatory agencies (e.g. FDA/ CVM, EMA) on dissolution topics
• 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 outside 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.
  

Other information:

• This position is located in Monheim am Rhein, Germany
• Language requirement: English
  

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