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!
Position Description:
Responsible for all aspects of data management support for Technical Development objectives in regard to data generated in formulation development and manufacturing process development experiments, analytical development, product stability testing or related Technical Development activities. In addition, the incumbent will be responsible for achieving global clinical data management objectives related to systems and processes used during data capture, including management of all data generated during technical development activities. This will include electronic and paper data collection processes and systems. This position is expected to be highly influential in partnering with Technical Development teams, scientists, and third parties to develop data management strategies that result in on-target and efficient delivery of data. This position will closely collaborate with appropriate internal and external functions, including Statistics, to ensure data integrity, data quality and process validation
Functions, Duties, Tasks:
• Compile, review, and process technical data based on lab journal entries of formulation development activities. manufacturing documentation, analytical laboratory testing or development reports.
• Manage, track, and communicate project milestones.
• Liaise independently with global stakeholders, seek feedback, and implement review comments.
• Follow Elanco’s specifications for good documentation practices.
• Maintain records in access-controlled folders and ensure audit compliance.
• Participate in department/company-wide initiatives.
• Strong ability to multi-task; able to handle multiple projects at different phases and different
registration types at the same time.
• Maintain a flexible work schedule to attend virtual meetings in European and US Time Zones.
Minimum Qualification (education, experience and/or training, required certifications):
• Master’s Degree in Life Science with experience in development of pharmaceutical
dosage forms or Laboratory experience with exposure to equipment and manufacturing processes applied in pharmaceutical industry. Strong affinity to handle large datasets, mindset to strive for optimization, accurate and efficient way of working
• Experience with data management tools, e.g., xls, jmp
• Knowledge and experience with different manufacturing processes, equipment and dosage forms (eg, for solid dosage forms: tablet compression, granulation, coating, extrusion
• Knowledge of pharmaceutical product characterization and analytical testing methods.
• Demonstrated ability to prepare technical development documents.
• Excellent oral and written communication skills with ability to communicate logically and
technically.
Additional Preferences:
• Knowledge of drug development guidelines
• Ideally, knowledge of Quality by Design (QbD) principles
Knowledge of iStability or Electronic Lab notebook
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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