At Ardelyx, you will experience an innovative and dynamic research and development environment. We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry’s best scientists in a team environment focused on world-class research and development. We currently have great opportunities for creative, experienced and talented individuals who want to join the Ardelyx team. We offer competitive compensation and benefits. Ardelyx, Inc. is an Equal Opportunity Employer.
Ardelyx® is building an integrated biopharmaceutical company with a gastrointestinal and cardio-renal focus. Our mission is to serve patients through the discovery, development and commercialization of minimally-systemic therapeutics that target intestinal receptors and transporters to address unmet medical needs.
We are seeking a highly motivated Senior Analytical Scientist to work within a collaborative, multidisciplinary drug development environment and help advance our portfolio of first-in-class drugs from clinic to commercialization.. In this key role, the successful candidate will oversee a group of research associate level analysts and will collaborate with other groups such as process development, formulation development, quality, regulatory and manufacturing. They will be responsible for establishing timelines, coordinating analytical activities, engaging matrix teams and ensuring timely delivery of analytical work packages to support CMC development from preclinical through commercialization. When needed, they will liaison with external partners, such as contract manufacturing organizations and labs, developing and implementing a comprehensive analytical control strategy. This position is best suited for someone comfortable working in a fast-paced team environment, willing to supervise associate scientists and able to work in the laboratory when needed.
• Oversee the development and validation of analytical methods for drug substances and drug products
• Conduct/manage routine and advanced analytical tests in accordance with SOPs and regulatory guidance.
• Write and or review protocols, reports, methods, standard operation procedure, and submission documents.
• Provide analytical support for formulation and process development.
• Perform independent scheduling and coordination of analytical activities
• Analyze analytical data, identify trends, and provide recommendations
• Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings
• Train and provide technical guidance to associate scientists.
• Troubleshoot analytical problems and conduct laboratory investigation and prepare laboratory investigation report
• Proactively provide suggestions on how to improve methods, lab practicees or lab systems
• Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.
• MS or PhD in Pharmaceutical, Analytical, or related Chemical field. Depending on education level, 10 or more years of direct experience in analytical pharmaceutical research and development
• Understanding of and experience applying ICH, USP, Ph Eur, FDA, and other relevant sources of guidance to CMC development
• Excellent organizational, oral and written communication skills
• Expertise in quality control, stability studies, method validations and characterization of new batches of APIs and Drug products
• Thorough knowledge of chromatographic techniques, dissolution methods, drug substance and product testing
• Proven record of method development, method qualification and technical transfer, and an ability to implement new methods and technologies
• Prior supervisory and timeline/deliverable management experience
• Ability to thrive in a multi-tasking, fast-paced and complex environment; responds with humor to challenging situations and ambiguity
• Ability to travel
As a member of the Ardelyx team, you will be part of the team that helps develop therapeutics that are designed to act in the gastrointestinal tract with minimal systemic exposure. Our drug candidates target important diseases and conditions. We are developing novel therapeutic agents that address unmet medical needs, with a gastrointestinal and cardio-renal focus.
We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world class research. Ardelyx offers a competitive total rewards package, perks and an innovative and dynamic culture.
Ardelyx, Inc. is an Equal Opportunity Employer.