Preclinical Research Associate; Scientist II-III

San Jose, CA 95106 Must be a US Citizen or Green Card holder.

The perfect candidate for this role would be a highly qualified Preclinical Research Associate in Gastrointestinal (GI), Central Nervous System (CNS), Cardiovascular (CV) and metabolic diseases.

The Preclinical Research Associate is responsible for assisting in all ongoing preclinical projects both in vitro and _in vivo and will help gather data to evaluate and improve the current drug delivery system. _ This person will be working with a multidisciplinary team of Scientists and Engineers to optimize the Rani platform.

MAJOR DUTIES AND RESPONSIBILITIES:

• Participate in complex _in vivo _studies, working closely with the Preclinical team and outside CROs
• Establish relationships with CROs for conduct of non-GLP as well as GLP studies
• Requires traveling to offsite CROs for conducting studies. This includes driving up to 2 hours each way; out of state travel may be required.  Work may entail spending several days out of town to oversee studies at the CRO sites
• Maintain laboratory equipment and supplies, ensuring proper calibration (if necessary) is conducted accordingly
• Must have excellent organizational skills and be able to record and manage experimental data from various experimental studies ongoing concurrently
• Support regulatory efforts through understanding of relevant standards and interpretation of FDA Guidance documents
• Actively participate in company-wide research meetings, including making detailed scientific presentations
• Work cooperatively with a multidisciplinary team of Scientists, Engineers, and personnel in other varying departments
• Contribute to hands-on in vitro laboratory work as needed, which may include isolated tissue experiments and ELISA/HPLC assays

Required Knowledge, Skills, and Abilities: (Submission Summary):

1. B.S., or M.S. in Animal Science, Animal Biology, or related field.

2. Familiarity with basic lab techniques (ex. Pipetting)

3. 3 years of in vivo research experience.

4. Experience in one or more therapeutic areas: Gastrointestinal (GI), Central Nervous System (CNS), Cardiovascular (CV) and metabolic diseases.

5. Cardiovascular (CV) and metabolic diseases Microsoft Office (Word, Excel, Powerpoint)

6. Research experience with large (non-rodent) animal models – a plus

7. Proficiency in English with effective written and oral communication skills

8. Ability to work in a fast pace environment; learn and become familiar with techniques in both the engineering and biological science

9. Experience with GraphPad Prism a plus5. CQE, CQA. – a plus

10. Experience in performing test method validation and Gage R&Rs. – a plus

11. Research experience with large (non-rodent) animal models – a plus

12. Industry / Contract Research Organization (CRO) experience – a plus