Ardelyx is a publicly traded biotech company focused on improving the lives of patients by developing and commercializing first-in-class targeted therapies that advance patient care. Using our discovery model, Ardelyx scientists have characterized new biological mechanisms and pathways that have enabled us to develop a pipeline of drug candidates to manage complications related to kidney and cardiovascular diseases. Our lead candidate, tenapanor, is a first-in-class small molecule therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease on dialysis. If approved, tenapanor could completely change the treatment paradigm in a disease state with significant unmet need. We are advancing the build of our commercial organization to be prepared for launch of tenapanor in mid-2021.
Scientist II- Pharmaceutical Chemistry & Formulation Development
We are seeking a Scientist II to join our Pharmaceutical Chemistry & Formulation team. The qualified individual will have at least 5 years’ experience in developing solid and liquid oral dosage forms for use in first-in-human studies through commercialization. The individual will be responsible for execution on sub-processes/projects within the pharmaceutics development activities. The scientist at Ardelyx plays the classic role of leading from the bench providing technical assessments for assigned projects that would feed into the larger strategy for developing clinical and commercial formulations. This is an excellent growth opportunity for a motivated scientist wishing to have the greater breadth of experience in an emerging Pharma company.
- This individual will support the Pharmaceutical Chemistry and Formulation activities at Ardelyx
- Drug Development responsibilities:
- Support cGMP manufacturing at our CMOs (includes review of batch records, specifications, deviations etc.)
- Execute experiments in-house based on capability and capacity or through an outsourced capacity as needed
- Support technical transfer of drug product manufacturing for agents in all stages of clinical development, including Validation and Launch
- Write experimental protocols and study plans with reports documenting the results
- Lead sub-teams with focused deliverables in formulation or process development
- Support pre-formulation and form screening efforts--collaborating with colleagues in Analytical, Medicinal and Process Chemistry--to help identify drug candidates with appropriate pharmaceutical properties
- S. or M.S. in Pharmaceutical Science or Chemical Engineering with at least 5 years’ experience in dosage form development, spanning pre-formulation through product launch. Expertise in experimental design and statistical analysis would be an advantage
- Demonstrated ability to work in teams internally and build and leverage external relationships with CMOs
- Willing to do hands-on work in the lab is a requirement (this could lead up to 80% of the time) and author development reports or support regulatory filing as needed
- Quick learner who can put new procedures and systems in place and suggest improvement ideas as applicable
- Able to bring new technologies or instruments in-house and provide training as needed.
- Ability to travel up to 20% of time (based on project needs)
As a member of the Ardelyx team, you will play a key role in developing and bringing to market first-in-class medicines to better the lives of underserved patients. It’s the patients in need that motivate and inspire us to be relentless and work hard every day. They push us to maintain a clear focus on scientific and clinical integrity with a commitment to medical innovation so that we can deliver exceptional medicines. We are different for good.
Ardelyx, Inc. is an Equal Opportunity Employer