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Skills
Analysis Skillsunmatched
Analytical Method Validationunmatched
Asepsisunmatched
Biomarkersunmatched
Biotech and Pharmaceuticalunmatched
Capsulesunmatched
Chemistryunmatched
Chronic Diseaseunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Drug Developmentunmatched
GLP (Good Laboratory Practices)unmatched
GMP (Good Manufacturing Practices)unmatched
Material Scienceunmatched
Mechanical Engineeringunmatched
Pharmacologyunmatched
Physiologyunmatched
Presentation/Verbal Skillsunmatched
Process Developmentunmatched
Quality Assurance Methodologyunmatched
Regulatory Requirementsunmatched
Reporting Skillsunmatched
Research & Development (R&D)unmatched
Safety Alertsunmatched
Safety Trainingunmatched
Safety/Work Safetyunmatched
Standard Operating Procedures (SOP)unmatched
Team Playerunmatched
Testingunmatched
Validation Planunmatched
Writing Skillsunmatched
Description
GENERAL INFORMATION
Position Title: Scientist I - III (Temp-to-Hire)
Department: CMC and Bioanalytic
Reports to: Associate Director, CMC and Bioanalytics
PURPOSE OF THE JOB
Rani Therapeutics has developed a disruptive technology, RaniPillTM capsule that facilitates the oral delivery of biologics. Working at Rani Therapeutics involves taking a multi-disciplinary approach based on traditional device technologies such as mechanical engineering and material science in combination with pharma-centric disciplines such as physiology, pharmacology, chemistry and protein therapeutics. This unique environment allows Rani Therapeutics to address the most complex, unsolved problem of oral biologics delivery. The candidate in this position will play a pivotal role in our R&D Department working on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically impact patient outcomes.
Job Duties
Conduct analysis or experiments by following procedures independently.
Conduct lot release and stability testing in compliance with GMP/GLP, safety and regulatory requirements to support all development stages.
Develop and execute experimental plan of limited scope (e.g. method development, characterization studies, instrument qualification) with minimum supervision.
Assist in developing and validating moderately complex analytical methods used to test raw materials, intermediates and final products or quantify biomarkers in biological matrices.
Help to improve existing complex methods with supervision.
Analyze and interpret complex data following procedures.
Learn and apply basic GMP/GLP principles.
Review test records according to procedures.
Responsible for safety in the laboratory, and alertness for the safety of co-workers and visitors.
Education and/or Job Experience
BS with a minimum of 5 years, MS with a minimum of 3 years of relevant pharmaceutical or biotechnology development experience. Position and compensation will be commensurate with experience.
Preferred Qualifications
Working knowledge in biophysical techniques and analytical characterization of peptides and proteins.
Experience in providing support to formulation development and process development.
Aseptic processing experience
Experience in authoring and revising standard operating procedures, work instructions, test methods, batch records, validation protocols, development reports, and validation reports.
Working experience in GLP/GMP regulated environment.
Excellent oral and written communication skills.
The ability to work as a member of a multidisciplinary team.