Careers

Join Our Team.

There has never been a more exciting time at Rani Therapeutics. We have successfully tested the RaniPill in humans, and we are working towards the ultimate goal of making the oral delivery of biologics a reality for millions of patients. We are growing rapidly and we are actively hiring.

Current Openings.

We are actively hiring and building our team. Check out some of our current open positions. If you think you have the right experience, and would like to be part of a dynamic team, we want to hear from you.

PRECLINICAL RESEARCH ASSOCIATE; SCIENTIST II-III

San Jose, California, United States - Full-time

Purpose of the job

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

Education and/or Job Experience

  • B.S., or M.S. in Animal Science, Animal Biology, or related field with at least 3 years of in vivo research experience
  • Experience in one or more therapeutic areas: Gastrointestinal (GI), Central Nervous System (CNS), Cardiovascular (CV) and metabolic diseases

Preferred Qualifications:

  • Research experience with large (non-rodent) animal models
  • Industry / Contract Research Organization (CRO) experience

Skills and Specifications

Competencies:

  • Proficiency in English with effective written and oral communication skills
  • Teamwork
  • Ability to work in a fast pace environment; learn and become familiar with techniques in both the engineering and biological sciences
  • Familiarity with basic lab techniques (ex. Pipetting)
  • Microsoft Office (Word, Excel, Powerpoint)
  • Experience with GraphPad Prism a plus
Apply Now

SR. QUALITY ENGINEER – cGMP

San Jose, California, United States - Full-time

Job Description  

The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for pharmaceutical and combination products.  This position requires technical expertise in Aseptic Techniques.  The Senior Quality Engineer is responsible for performing a quality role for the aseptic manufacturing, quality systems and compliance in accordance with cGMP, related company SOP’s, federal laws, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products. 

Job Requirements

  • Maintain and improve Rani Quality System in accordance with FDA Regulations and ISO 13485 requirements
  • Provide hands-on direction for aseptic process and cGMP manufacturing activities
  • Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
  • Collaborate with cross functional teams Manufacturing, Engineering, Facilities to ensure adherence to cGMP guidelines
  • Conduct investigations for issues associated with audits, lot history records and complaints. Approve manufacturing and testing deviations and investigations
  • Evaluation and support for implementation of new processes, lead continuous improvement of aseptic / sterile processes
  • Lead and support qualification and validation of cGMP equipment, facilities, utility systems, analytical test methods, cleaning and manufacturing processes. These duties will include, but are not limited to: the implementation and documentation of these validations and their lifecycle management in compliance with FDA and EU regulations
  • Manage the deviation system, perform QA assessment of deviations and ensure that all assessments are completed, review and approve deviation reports
  • Assist in the review and approval of lot history records and test records
  • Conduct audits at CMO, testing operations and internal audits
  • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ), summary reports, ensure qualifications are conducted in accordance with the Validation Master Plan
  • Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
  • Lead the resolution of quality issues related to non-conformance reports and CAPAs
  • Develop and initiate sampling procedures and statistical process control methods
  • Address systemic quality issues with suppliers or internal groups
  • Evaluate product changes for qualification and validation requirements and assist in change implementations
  • Other duties/ activities may be necessary to support departmental or company goals

Education and Job Experience

  • Bachelor’s degree or higher in Chemistry, Biology, or equivalent scientific discipline
  • A minimum of 7 years quality assurance/engineering experience within the pharmaceutical or biopharmaceutical industry is required
  • cGMP experience is required
  • Experience with performing utility qualification activities for vaporized hydrogen peroxide (VHP) system is preferred Excellent communication skills both oral and written
  • Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations
  • Experience with FDA Regulations (21 CFR part 820, part 210 and part 211) and ISO Standards (ISO 13485 and ISO 14971) is required
  • Experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)

Skills and Specifications

  • Ability to motivate and influence people
  • Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
  • Ability to create and provide training
  • Good statistical and numerical ability
Apply Now

RESEARCH SCIENTIST II

San Jose, California, United States - Full-time
Description

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 Research scientist plays a pivotal role in our R & D department on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically impact patient outcomes. 

Requirements
  • To design and undertake high quality scientific experimentation resulting in formulation and process development of parenteral dosage forms.
  • Demonstrated experience in immediate and sustained release parenteral formulations.
  • Extensive knowledge in advanced drug delivery systems and their pharmaceutical applications, such as emulsions, suspensions, polymer, nanoparticle, PLGA microspheres and colloidal systems
  • Design novel device components to advance device pill development.
  • To assess the chemical and physical stability of formulations in collaboration with analytical departments and to identify appropriate stability, manufacturability, and performance issues.
  • To interpret scientific data to derive clear  conclusions and contribute to the direction for future work.
  • To communicate effectively to the project team and present data at team meetings.
  • To maintain high quality documentation of all activities in notebooks, reports as required.
  • Participate in tech transfer from R&D to Manufacturing as appropriate
  • Keep up to date with relevant scientific and technical developments.

Education and/or Job Experience

  • M.S. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or related fields.
  • Must have 3+ years of pharmaceutical or biotechnology research experience.
  • Title will be commensurate with experience

Skills and Specifications

  • Experience in working with drug-device combination products is a plus
  • Experience of working in GLP/GMP regulated environment.
  • Excellent oral and written communication skills.
  • The ability to work as a member of a multidisciplinary team. 
Apply Now

RELIABILITY ENGINEER

San Jose, California, United States - Full-time
Description

We are seeking a Reliability Engineer to perform hazard evaluation, failure analysis and develop risk mitigation strategies in a regulated, biotech environment.  The position will work closely with R&D, manufacturing, process, packaging and quality to provide guidance on the reliability of new product designs that will ensure sustained robustness.  The position will also lead the effort to design relevant experiments, collect/analyze data and make sound recommendations to achieve high reliability as the company grows and scales up.    

Requirements
  • Actively participate in engineering design reviews and define appropriate metrics to measure/evaluate product reliability
  • Develop/conduct Design of Experiments (DOE) and reliability studies that would lead to  understanding of multiple variables that may affect product performance    
  • Define/establish test methods and statistical process control procedures to achieve desired product reliability
  • Propose/recommend appropriate materials, components and engineering concepts that minimize or eliminate the risk of failure 
  • Determine statistical sample size required for technical reliability studies 
  • Evaluate the current manufacturing hardware/software/process and make recommendations for achieving high reliability as the company scales and gears up for increased production throughput 
  • Work with internal engineering team as well as outside service providers to qualify new components, equipment and  processes from reliability standpoint
  • Using statistical software tools such as Minitab, perform data analysis, prepare relevant presentations/documentations/reports, highlight reliability issues and make appropriate recommendations 
  • Create appropriate infrastructure and set high standards for achieving/maintaining quality and reliability      
  • Review design changes for their impact on Quality and Reliability 
  • Participate and actively contribute to continuous improvement efforts that will streamline and improve the reliability process
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications

  • BS degree in physics or mechanical Engineering or related technical field
  • 5-7 years of relevant engineering reliability experience in complex medical technologies
  • Must be hands-on and  be able to independently develop and perform experiments 
  • Extensive experience with mechanical/environmental stress, shock, drop, vibration and accelerated testing
  • Proven track record in a regulated environment , ISO, cGMP and QMS standards
  • Proficient with applying DOE, statistical analysis tools such as Minitab, dFMEA, pFMEA and other techniques to identify failure modes at system, sub-system and component level
  • Excellent verbal, written, presentation and interpersonal skills
  • Strong analytical and problem-solving skills 
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

  • MS or PhD in physics, engineering or equivalent
  • Knowledge/experience with polymers and processes such as injection molding and pressure forming
  • Familiarity with sterilization process

Travel

Up to 10%

Apply Now

SENIOR MECHANICAL ENGINEER

San Jose, California, United States - Full-time

Job Summary

We are seeking an exceptional Senior Mechanical Engineer to design, develop and validate semi or fully automated equipment that are used for the scale-up of high volume, disposable devices.  Your role is to find creative and sound engineering solutions to challenging problems with strong focus on quality, reliability and execution.  This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Biology, Quality, Facilities and Sustaining.

Responsibilities

  • Develop concepts and ideas for improving exiting tooling as well as creating new tooling including semi-automation where applicable
  • Evaluate the current manufacturing processes & workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials as well as soliciting feedback from operators
  • Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch and documentation
  • Create 3D models, engineering drawings and bills of materials
  • Create comprehensive work instructions and manufacturing SOP’s
  • Create verification/validation protocols (IQ,OQ,PQ), lead/support the execution activities, generate relevant data and provide corresponding documentation and reports
  • Participate in design FMEA and plan steps for mitigating risks
  • Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications

  • Bachelor’s Degree in Mechanical Engineering
  • 5-7 years hands-on, relevant experience
  • In-depth experience with complex mechanical/electromechanical design
  • Extensive experience with precision mechanisms, pneumatics, servo systems, tooling/fixtures and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
  • Experience with creating engineering drawings, BOMs and product specifications
  • Deep knowledge of material properties, heat treatment and surface finish
  • Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP and QMS standards
  • Good understanding of DFM and lean manufacturing
  • Excellent verbal, written, presentation and interpersonal skills
  • Strong analytical and problem-solving skills
  • Knowledge and/or hands-on experience with machine shop tools
  • Deep knowledge of GD&T as well as proficiency with SolidWorks
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

  • Master’s degree in Mechanical Engineering or equivalent
  • Knowledge/experience with plastic injection molding
  • Knowledge/experience with DOE, SPC, JMP /Minitab
  • Experience with metal stamping, laser cutting and chemical etching
  • Familiarity with and sterilization process and aseptic environment
  • PLC programming

Travel

Up to 10%

Apply Now

ASSEMBLER

San Jose, California, United States - Full-time
Description

Primary job function is to assemble parts and components used in the manufacture of medical devices. 

Requirements
  • Perform assembly operations requiring fine hand dexterity.
  • Understand and comply with Good Manufacturing Practices and Good Documentation Practices.
  • Comply with work schedules and properly report hours worked.
  • Have the ability to initial and date and write notes and other entries legibly.
  • Comply with all written procedures and safety practices.
  • Read and understand procedures written in English.
  • Assist in writing and updating assembly procedures, protocols and checklists. 
  • Evaluate problems and make initial recommendations for possible corrective actions for issues encountered on the line.
  • Work with production management and Quality Assurance to provide feedback regarding assembly procedures. 
  • Assure product and process quality by following Quality System procedures.
  • Maintain product and company reputation by complying with government regulations.

Education, Training, Skills and Experience Requirements: 

  • High School Diploma or equivalent 
  • 2+ years of experience in Medical Device or Pharmaceutical company
  • Must have good English written and verbal communication skills
  • Good arithmetic skills are required
  • Mechanical aptitude desired 
  • Medical device experience is preferred 
  • General proficiency of Microsoft Excel and Microsoft Word     
  • Contributes to team effort by accomplishing related results as needed.
  • Flexible demeanor and comfortable dealing with uncertainties 

Physical Demands: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  

  • While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time.
  • Physical on site presence is required
Apply Now

SENIOR MANUFACTURING SUSTAINING ENGINEER

San Jose, California, United States - Full-time
Description

Supports the manufacturing of Rani Capsules. Works with engineering and quality to ensure device specifications conform to device requirements. Responsible for supporting the production lines with daily activities, process improvements, cost savings projects, customer/vendor changes, and consistency of assembly processes.

Requirements
  • Evaluate the current manufacturing processes /workflows to identify opportunities for improving 
  • Improve manufacturing efficiency, production yields, product quality, and consistency through equipment and product design, modifications, and fabrication.
  • Modify and improve existing equipment.
  • Complete projects, report status, and document lessons learned in an efficient manner.
  • Finalize manufacturing methods for medical devices.
  • Provide assistance for equipment design or producing medical devices and components.
  • Support production and manufacturing.
  • Engineering support which includes vendor contact and auditing specification.
  • Responsible for implementing tooling maintenance and upgrades.
  • Responsible for manufacturing methods and their transfer into production.
  • Follow SOP on re-validation of existing equipment, tooling and processes.
  • Develop improved processes, sampling activities, as well as tooling and manufacturing concepts that will meet customer expectations on cost, quality and delivery.
  • Provide technical assistance and engineering support to the manufacturing floor in ensuring production of quality products. Work with other support departments to maintain on-time delivery of goals.
  • Lead process improvement and waste elimination efforts through application of lean principles and actively participate in continuous improvement events.
  • Work with Quality Control team to generate, update and implement all project related requests, process guides, and troubleshooting guides.
  • Performs Root Cause Analysis and Addresses CAPA on Manufacturing Non Conformances
  • Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)

Qualifications

  • BS in Mechanical Engineering, Manufacturing Engineering, or similar related field
  • 7+ years of engineering experience in manufacturing preferred
  • MiniTab (or other statistical analysis software), SolidWorks or CAD modeling software.
  • Experience in new product development, introduction processes and procurement protocols
  • Must be detail oriented, focused and able to produce accurate and professional documents
  • Must have excellent interpersonal skills and ability to communicate needs and demands in an effective manner.
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc. 
Apply Now

ASSOCIATE DIRECTOR FORMULATION GROUP

San Jose, California, United States - Full-time
Description

The Biologics Formulation Group Director oversees the activities of the formulation group, supporting the formulation development and preclinical studies within timeline and budget. Develop functional plans for managing formulation activities, including activities to be performed in-house or through third-party relationships.

Requirements
  • Define and execute formulation strategy for all pipeline programs
  • Provide a science-based approach to formulation optimization for extended-release solid dose: identify excipients and optimize formulation composition for lead candidates
  • Provide full support for CMC activities, interface with R&D and manufacturing 
  • Design and conduct in vitro and in vivo experiments in collaboration with the Preclinical Group to test and optimize new formulations
  • Responsible for documentation of all test results and written reports
  • Provide technical input and oversight related to formulations including development work outsourced to CDMOs and contracting testing laboratories
  • Provide functional leadership, including: hire and manage a professional, high performing staff; develop talent and make promotion recommendations
  • Drive accountability, consistency, quality, and process standardization
  • Collaborate with bioanalytical group, preclinical group, engineering, quality assurance, manufacturing, and senior management 
  • Maintain knowledge of emerging techniques, equipment and applicable regulations (e.g., ICH for stability, specifications, etc.) 
  • Work closely with the senior scientists and R&D team to ensure alignment and prioritization of formulation work
  • Ensure knowledge management and preserve all forms of intellectual property generated from the above activities

Qualifications

  • M.S. or Ph.D. in biochemistry, chemical engineering, pharmaceutical sciences, pharmacology, polymer chemistry, or a related discipline with 10+ years of directly relevant industry experience
  • Deep experience in formulation development of biologics; experience in combination product is a plus
  • Leadership experience, with the ability to attract, motivate and retain top talent
  • Ability to manage multiple projects and priorities
  • Strong drive for excellence
  • A hands-on attitude to leadership and passion for team development 
  • Experience with project management and maintaining budget 
Apply Now

MECHANICAL ENGINEER

San Jose, California, United States - Full-time
Description

We are seeking a candidate for mechanical testing and fixture design. You should have a good understanding of how to design and set up tests. You will be responsible for designing unique tests, developing fixtures, and analyzing the data. Additional duties may include reporting failures, and assisting in improving manufacturing processes to prevent prototype failures. As a Mechanical Engineer, your role is to support R&D with component design work, test fixture design, and supporting verification testing. You will also interface with manufacturing to implement new design updates in to the pilot manufacturing line. 

Requirements
  •   Work with multi-disciplinary teams to define tests and perform verification testing
  • Design and build appropriate test fixtures for completing the tests 
  • Assist engineering and bio team on evaluation of device failures and complete test reports to review improvements with the team 
  • Collaborate with manufacturing to create product assembly tooling, fixtures and work instructions
  • Assist R&D and manufacturing in process development, including molding, bonding processes for parts, and component design
  • Comply with company’s policies and guidelines regarding quality and regulatory

Qualifications

  • BS in Mechanical Engineering 
  • 3-5 years of industry experience
  • Must be hands on and adept at building and debugging fixtures 
  • Fluent with SolidWorks 
  • Excellent verbal, written, presentation and interpersonal skills
  • Strong analytical and problem-solving skills 
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

  • Prior experience in a medical device company desired

Travel

Up to 10%

Apply Now

MANUFACTURING PROCESS ENGINEER

San Jose, California, United States - Full-time
Description

Supports the manufacturing of Rani Capsules. Works with engineering and clinical to ensure device specifications conform to device requirements. Responsible for establishing baseline by evaluating the current manufacturing processes and making improvements to increase productivity, quality /reliability, and reduce cost and scrap

Requirements
  • Evaluate the current manufacturing processes /workflows to identify opportunities for improving productivity and quality while reducing cost /labor 
  • Perform process capability studies via DOE’s. Utilize statistical data analysis to arrive at sound conclusions and follow up with action plan for process improvements 
  • Develop standards and monitoring techniques to reduce variability in manufacturing that may include operator, material, equipment and processes 
  • Actively participate in discussions with appropriate functions and contribute to new initiatives that may include design, manufacturing, process /quality improvement as well as cost reduction
  • Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution
  • Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)
  • Works with Development Engineers to effectively transfer new products to Manufacturing 
  • Complete design and development projects by training and guiding technicians and assemblers
  • Create verification /validation protocols (IQ,OQ,PQ), lead the execution activities, generate relevant data and provide corresponding documentation and reports
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation 

Qualifications

  • Bachelor’s Degree in Mechanical, Chemical, Manufacturing or related engineering fields
  • 3-7 years hands-on experience in a manufacturing environment with proven track record of process development /optimization and validation
  • Excellent verbal, written, presentation and interpersonal skills
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc. 
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
  • Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC and process development/validation
  • Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines  /processes
  • Knowledge of material science and polymer chemistry
  • Diverse background in process characterization and optimization in a manufacturing environment. 
  • Hands-on proactive approach to problem solving
  • Requires interaction and collaboration with a cross-functional team

Preferred Qualifications

  • Experience with Statistical Software tools such as Minitab or JMP 
  • Knowledge and/or hands-on experience with metrology tools such as CMM, Micro-Vu, SEM, etc.
  • Familiarity with cleaning and sterilization processes 
  • Working knowledge of Solidworks 

Travel

  • Up to 10%
Apply Now

PROCESS ENGINEERING MANAGER

San Jose, California, United States - Full-time
Description

The Manager of Process Engineering is responsible for providing technical leadership and direction to a team of talented engineers. The successful candidate will have extensive experience in the areas of process development/optimization, continuous improvement, and cost reduction as well as verification & validation activities in a fast-paced environment. 

This is a hands-on position that requires interaction and collaboration with cross-functional teams including R&D Engineering, Automation Engineering, Manufacturing, Material, Quality, and safety. 

Requirements
  •   Develop standards and key performance metrics to reduce variability as well as improving quality, throughput, and efficiency 
  • Actively participate in early design concept reviews with R&D and Automation Engineering and provide objective feedback to ensure manufacturing robustness
  • Perform equipment characterization and define process windows by creating appropriate DOE’s and utilizing statistical data analysis
  • Own the verification/validation activities including generation of IQ/OQ/PQ protocols, execution and final reports as well as creating SOP’s, MPI’s LHR’s and providing appropriate training
  • Recommend production layouts for automation equipment and material flow for maximum efficiency
  • Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution
  • Provide support for existing equipment and ensure proper documentation and training
  • Lead new product transfer and manufacturing scale-up activities utilizing best manufacturing techniques
  • Champion and foster a mindset of quality and continuous improvement 
  • Adhere to project timelines, identify risks/issues, and recommend mitigations
  • Attract/hire top talent and ensure retention by providing coaching/mentoring and encouraging career growth 
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications

  • Bachelor’s Degree in Chemical, Mechanical, Manufacturing, or related engineering fields
  • 5-7 years hands-on experience in the medical device field with proven track record of process development/optimization and validation
  • Minimum 3 years of proven leadership and people management
  • Excellent verbal, written, presentation and interpersonal skills
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards
  • Strong analytical and problem-solving skills including but not limited to DOE and statistical data analysis
  • Extensive experience with process capability studies, FMEA, GR&R, SPC and process development/validation
  • Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines/processes
  • Knowledge of material science and polymer chemistry
  • Experience with Statistical Software tools such as Minitab or JMP
  • Experience with Lean manufacturing 

Preferred Qualifications

  • Advanced engineering degree
  • Familiarity with aseptic manufacturing
  • Project management experience 
  • Knowledge and experience in plastics assembly techniques

Travel

  • Up to 10%
Apply Now

MANAGER/SR. MANAGER CMC ANALYTICAL DEVELOPMENT

San Jose, California, United States - Full-time
Description

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.

Requirements
  • Comprehensive knowledge of state-of-the-art analytical techniques such as various HPLC modes and detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell-based assays, etc., for product characterization, comparability testing and PK/PD analyses.
  • Hands on experience in stage appropriate method validation and specification setting.
  • Assessing chemical and physical stability of formulations and identifying appropriate stability, manufacturability, and performance critical quality attributes.
  • Proven expertise in establishing and managing reference standard and stability programs.
  • Experience in protein purification and biologic formulation is a plus.
  • Participate in method and tech transfer from R&D to Manufacturing as appropriate.
  • Experience in writing, reviewing and approving CMC sections of regulatory filings.
  • Good working knowledge of GMP requirements, including ICH, FDA, and EMA guidelines, for development and manufacturing of drug products and/or drug-device combination products (a plus).
  • Assessing utilization of resources and identifying when, and where additional resources may be needed.
  • Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation.
  • A track record in collaboration with cross functions, including (but not limited to) Process/Engineering Development, Formulation/Drug Product Development, Manufacturing, Quality Assurance, and Regulatory Affairs, is required.
  • To communicate effectively to the project team and present data at team meetings.
  • To maintain high quality documentation of all activities in notebooks, reports as required.
  • Keep up to date with relevant scientific and technical developments.

Education and/or Job Experience

  • B.S./M.S. or advanced degree (preferred) in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or related fields.
  • Must have 5+ years of relevant pharmaceutical or biotechnology development experience.
  • Position and compensation will be commensurate with experience.

Skills and Specifications

  • A track record in biologics analytical development, particularly, experience in biophysical techniques and analytical characterization of peptides and proteins is a must.
  • Working knowledge in product formulation (solid oral dosage, and/or parenteral sustained release) and process development from early to late phase development or at minimum hands on experience in providing analytical support to these activities.
  • Experience of working in GLP/GMP regulated environment.
  • Experience in working with drug-device combination products is a plus.
  • Excellent oral and written communication skills.
  • The ability to work as a member of a multidisciplinary team.
 
Apply Now

SENIOR AUTOMATION ENGINEER

San Jose, California, United States - Full-time
Description

We are seeking an exceptional Senior Automation Engineer to design, develop and validate controller system hardware and software for semi or fully automated equipment that are used for the scale-up of high volume, disposable devices. You will be analyzing system requirements, creating electrical and pneumatic schematics as well as panel layouts, implementing custom programmable logic code, testing system functionality and efficiency, proving system safety, and providing operational support.

Requirements
  • Working closely with R&D, Manufacturing, and Process Engineering groups to develop concepts and ideas for automation where applicable
  • Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch and documentation
  • Develop engineering designs, including electrical schematics, panel layouts, and bill of materials for equipment. Knowledge of SolidWorks Electrical is a plus
  • Hands on PLC Controls system design, development, programming, and validation
  • HMI/GUI design and implementation. Apply human factors and usability engineering in the development and modification of software interfaces
  • Enable remote management of PLCs, controllers, and HMIs, as well as data logging 
  • Work with sustaining and maintenance to understand the root cause of control-related failures.
  • Provide engineering support, technical guidance, and training to operators
  • Able to work on multiple projects simultaneously in a fast-paced, energetic environment and manage competing priorities. Strong planning and organizational skills
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Education and/or Job Experience

  • Bachelor’s degree in software engineering, mechanical engineering, electrical engineering, or a related field
  • 5-7 years of hands-on, relevant experience

Qualifications

  • Proficiency expected in one of the following: Allen-Bradley (RSLogix 5000), Siemens, Omron, and or other industry standard PLC platforms
  • Working knowledge of Relay Ladder Logic (RLL). Understanding of Structured Text (ST), Functional Block Diagram (FBD), and Sequential Function Charts (SFC)
  • Experience in writing HMI user interface using FactoryTalk View and other industry standard Graphic User Interfaces
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Ability to troubleshoot equipment problems and perform complex system tests
  • Ability to work with minimal supervision

Preferred Qualifications

  • Advanced engineering degree
  • VFD programming and motor control. Working knowledge with SMC motor driver preferred
  • Experience with robotics (Epson, Denso, Omron), and machine vision
  • PLC technical certification
Apply Now

SENIOR MECHANICAL DESIGNER

San Jose, California, United States - Full-time
Description

We are seeking a Mechanical designer to support a wide variety of engineering activities in a fast-paced environment.  This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Process and Quality.

Requirements
  • Create 3D models and detail drawings by reverse engineering existing tooling and fixtures
  • Work closely with the Engineering and Manufacturing teams to understand design intent and incorporate Geometric Dimensioning and Tolerancing (GD&T)
  • Design new jigs and fixtures for Manufacturing
  • Perform tests and experiments when necessary to collect functional data as it relates to the current tools design  
  • Create complete documentation package including Drawings, BOM’s, work instructions, MPI’s, etc. and release on ECO
  • Provide design and documentation support to R&D and Manufacturing Engineering teams 
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation 

Qualifications

  • Minimum 3 years of hands-on experience in a manufacturing environment 
  • Good understanding of mechanical/electromechanical design
  • Experience with mechanisms, pneumatics, fixtures/tooling and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
  • Experience with creating engineering drawings and BOM’s 
  • Excellent verbal, written, presentation and interpersonal skills
  • Good understanding of GD&T as well as proficiency with SolidWorks
  • Familiarity with metrology tools
  • Associate degree in a technical field

Preferred Qualifications

  • Knowledge and/or hands-on experience with machine shop tools
  • Knowledge/experience with electrical /electronics 
  • Knowledge/experience with plastic injection molding
  • Experience with Micro-Vu 
  • Prior experience with FDA regulations, ISO, cGMP and QMS standards
  • Understanding of DFM and lean manufacturing

Travel

Up to 10%

Apply Now

CHIEF TECHNICAL OFFICER (CTO)

San Jose, California, United States - Full-time
Description

The CTO is an important part of the Company’s management team, reporting to the CEO and leading the R&D and engineering departments. Provide strategic and technical leadership and ensure organizational excellence.

Requirements
  • Oversee all research and development efforts including refinement and further development of Rani’s core platform technology and the development of commercial products from preclinical stage through market launch
  • Develop and execute an R&D plan in support of Rani’s business strategy. Understand the business and make strategic recommendations around R&D efforts in the context of the goals of the business
  • Align technology/R&D goals to other departmental and organizational objectives
  • Provide direct supervision of all R&D staff (including Product Development, Research) and outsourced work with consultants, advisors, and vendors
  • Define the R&D organizational structure and drive recruitment of new R&D staff; define most effective manner to build team for fast-paced growth and long term success of the company 
  • Partner with cross-functional teams in bioanalytical/clinical/regulatory to develop overall R&D strategy and plans including key deliverables, corporate goals & objectives, timelines, budget projections, and key decision points
  • Support manufacturing, pre-clinical and clinical trials, and regulatory submissions as needed
  • Ensure R&D activities maintain Rani’s technology and IP leadership position 
  • Effectively communicate strategy to company stakeholders including potential partners and investors, as needed
  • Work closely with the management team to participate in the development of strategies around product roadmap
  • Provide sustaining engineering support for existing products
  • Help build and drive a positive, passion-to-win culture

Qualifications

  • B.S. / M.S. in engineering, life sciences, or a related field; MBA a plus
  • 15+ years of experience leading R&D and product development teams within a biotech, medtech, or life sciences company
  • Ability to solve complex engineering-related challenges
  • Experience leading a high-performing company division or functional group
  • A hands-on attitude to leadership and passion for team development, with the ability to attract, motivate and retain top talent
  • Exceptional team management skills and ability to delegate efficiently 
  • Ability to quickly transition between strategic and tactical thinking
  • Strategic thinking, creativity, and problem-solving skills
  • Strong communication skills
 
Apply Now

CHIEF OF STAFF - BIO TEAM

San Jose, California, United States - Full-time
Description

We are looking for a motivated, adaptable, whip-smart individual to support our Chief Scientific Officer (CSO) as Chief of Staff, Bio Team. The right candidate will be a driven self-starter with high EQ, first-rate analytical and communication skills, and a commitment to executing with urgency and improving operations. This is an opportunity for significant learning and upward mobility, as the right candidate will be well positioned to become a pharma leader, go to business school, or even start their own company in the future. Working closely with the CSO, you’ll get unparalleled mentorship, learn a ton, and make a big impact on the organization.

This role reports directly to the CSO and will involve working as a consultant, coordinator, and implementer to support and enhance the CSO function. The Chief of Staff, Bio Team contributes to the success of the bio organization (including bioanalytics, formulation, and preclinical development) by leading and advising on strategic planning activities and driving business management and operations activities that support the CSO.  

About the CSO

Mir Hashim is Chief Scientific Officer at Rani Therapeutics and joined in 2012. Prior to Rani, he held roles of increasing responsibility at pharma giant GlaxoSmithKline, including as Head of Pharmacology. He holds a Ph.D. in pharmacology.

Requirements
  •   Be a thought-partner and trusted advisor to the CSO on business, organizational, and operational strategies and solutions
  • Understand the strategic, big picture priorities while managing the detailed execution of deliverables
  • Organize and prioritize critical issues and required information for the CSO to facilitate efficient decision making
  • Drive and execute complex and cross-functional initiatives in a timely manner on behalf of the CSO
  • Assess inquiries directed to the CSO, determine the proper course of action, and delegate to the appropriate individual to manage
  • Act as the liaison between the CSO and bioanalytical / preclinical teams to ensure consistent communication, involvement and decision-making at the proper time
  • Manage bio team meetings, including preparing agendas and ensuring time is well spent and objectives are achieved
  • Build and maintain strong relationships within the bio organization in order to advise and influence outcomes
  • Navigate ambiguous situations to unearth and address core issues or challenges
  • Independently lead and drive cross-functional initiatives, projects or programs
  • Facilitate resolution of issues relating to projects, priorities and team dynamics

Qualifications:

  • B.S. / M.S. in biological sciences, pharmaceutical sciences, biomedical engineering, or related field; foundational knowledge of biology and physiology is required
  • 2+ years of experience in drug development, life sciences, or pharma consulting
  • Insatiable intellectual curiosity
  • Proven track record of effectively partnering with executive leaders in scientific/technical organizations
  • Experience in business operations and/or project management a plus
  • Highly skilled in strategic thinking, planning, and execution
  • Excellent written and verbal executive communication skills
  • Significant entrepreneurial drive, ability to create order from chaos, and willingness to roll up sleeves to directly solve challenging problems where required
  • Demonstrate the ability to be effective in dealing with ambiguities; fast and effective problem solving
  • Ability to retain focus on long term goals while addressing high switching frequency for short term actions
Apply

SENIOR ELECTRICAL ENGINEER

San Jose, California, United States - Full-time
Description

We are seeking an exceptional, highly motivated, and hands-on Senior Electrical Engineer to design, develop and validate novel circuits for medical devices and other non-conventional application circuits. Your role is to find creative and sound engineering solutions to challenging problems with strong focus on quality, reliability, and execution. This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, and Biology.

Requirements
  • Collaborate with cross-functional teams to shape future technology integration into our products and define electrical specifications and requirements.
  • Hardware engineering duties include component analysis, circuit design, schematic capture, component placement, PCB routing, prototype bring-up and general debugging.
  • Analog and mixed-signal design and simulation (discrete transistors, op-amps, filters, advanced sensors integration)
  • Digital design (microcontroller, memory, digital interfaces such as I2C/SPI, UART, USB)
  • Wireless protocol integration (Bluetooth and Wi-Fi)
  • Electrical functional verification and signal characterization of all designs. 
  • Develop test plans and systems to test designs in lab and manufacturing environments.
  • Model, analysis, and documentation of risks and mitigation strategies, optimizations for efficiency, manufacturability, testability, and overall user experience.
  • Firmware engineering duties may include overall architecture, power management optimization, code implementation, testing and maintenance. 

Education and/or Job Experience

  • Bachelor’s degree in electrical engineering or a related field
  • 5-7 years of hands-on, relevant experience

Qualifications

  • Must demonstrate strong EE and firmware fundamentals.
  • Must have hands-on experience in prototype bring-up and debugging, functional verification, and manufacturing support. Ability to solder and rework is a plus.
  • Broad experience in low power embedded system design, including architecture development, component selection, schematic capture, PCB layout, and prototype development. Working experience with Altium Designer is a plus.
  • Deep understanding of wireless communication software and firmware architectures. Experience with Bluetooth LE is preferred.
  • Must demonstrate strong verbal and written communication skills.
  • Strong analytical and problem-solving skills.
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks.

Preferred Qualifications

  • Master’s degree in Electrical Engineering or equivalent
  • Knowledge/experience with ultralow power design
  • Knowledge/experience with RTOS with BLE stack
Apply

QUALITY INSPECTOR

San Jose, California, United States - Full-time
Description

The Quality Inspector is responsible for supporting all receiving inspection activities, including all aspects of inspection (receiving, first article inspection and in-process). Perform visual and dimensional inspections as defined by our Standard Operating Procedures and Engineering Drawings. This position will be required to determine accept / reject disposition based on inspection results. As the Quality Inspector, you will support the Development and Production/Manufacturing departments with inspections of materials/parts/products, while maintaining compliance with Quality Management System (QMS) procedures. 

Requirements
  • Perform inspection of parts/materials received, in-process, and finished products for conformance to specifications and in accordance to QMS procedures 
  • Perform inspection using a variety of standard metrology equipment, including: Micro-Vu, height gauge, pin gauges, calipers, micrometers, surface table, gauge blocks, dial indicators, durometer, etc.
  • Read engineering drawings and interpret geometric dimensioning and tolerance, be able to perform inspection with minimal supervision
  • Determine inspection sample size based on procedures, specifications, and standards. 
  • Perform analysis per the established procedures/specifications to make pass/fail decisions
  • Document inspection activities in accordance to quality procedures and Good Documentation Practices
  • Maintain accurate records as per Document Control procedures
  • Report discrepancies and issues to QA Lead and affected function(s)
  • Initiate NCMRs when failed results are obtained or discrepancies are observed during the inspection process
  • Assign and apply expiration dating labels to materials/parts, as per the specifications/quality procedures
  • Interact closely with different functions of the organization
  • Assist in the development of inspection methods to support products under development
  • Performs other duties as needed to support the Quality Assurance Department and the company

Education and/or Job Experience

  • Minimum of 3 years of experience performing inspections
  • Micro Vu or similar CMM experience is required
  • Experience with AQL Sampling using C=0 Sampling Plan
  • Knowledge and use of precision testing equipment and tools
  • Government Regulated Environment experience such as FDA and ISO
  • Must have adequate computer experience (knowledge of Microsoft Word, Excel)
  • Experience working in a cGMP environment

Skills and Specifications

  • Attention to detail and organizational skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
Apply

EQUIPMENT ENGINEER

San Jose, California, United States - Full-time
Description

The Equipment Engineer is responsible for planning, coordinating and directing the operations of all equipment for effective calibration, maintenance and repair programs. This position organizes the arrangements for technical evaluation of equipment, purchase orders, planning, and scheduling of all calibration and preventive maintenance activities internally and by outside approved suppliers. Reviews and tracks the records, inspections, calibrations, and service agreements for the organization’s equipment and tools. The position acts as a technical advisor on all equipment issues and technical feedback to the management team with equipment including but not limited to use, budgets, and potential equipment purchases. This position works closely with all Rani departments to ensure adherence to the Rani Equipment Calibration and PM procedures. 

Requirements
  • Update calibration and PM procedures and forms within the Quality Management System as needed
  • Review all equipment specification information for completeness and appropriateness for the usage of the equipment 
  • Qualify equipment to ensure the fulfillment of all requirements including IQ/OQ validation and verification activities. Ability to create and execute quality documentation for internally and externally designed production equipment 
  • Determine troubleshooting, maintenance, and calibration procedures for each piece of equipment and train relevant personnel to perform them.  Participate in troubleshooting and repair of test equipment as required
  • Thoroughly document all aspects of the equipment, including its requirements, design, operation, and qualification in compliance with Good Manufacturing Processes (GMP).
  • Initiate equipment specifications for calibration information by collaborating with equipment owners, such as calibration parameters, tolerances and intervals
  • Developing detailed reports or instructions to show how to calibrate/PM a new machine
  • Review equipment specifications for the appropriateness of all preventive maintenance requirements
  • Manage and maintain equipment database and equipment files 
  • Ensure appropriate labels are affixed to the equipment and tools, such a “No Calibration or PM Required”
  • Collect, report, and monitor calibration/PM performance metrics monthly and report to the QA management
  • Ensures scheduling of outside sources in accordance with established calibration frequencies and initiating supplier approval process if needed
  • Coordinates with equipment owners and departments to issue and control all scheduled equipment due for calibration and PM and ensure to communicate the risks of possible scheduling challenges
  • Ensures and verifies that any calibration/PM service providers are approved suppliers per Rani procedures
  • Monitor CAL/PM schedule to ensure necessary equipment is properly calibrated/PM’ed in a timely manner
  • Review all calibration and preventive maintenance records and certificates for accuracy and completeness, as per internal procedures.
  • Initiate an NCMR and report any out of tolerance (OOT) results, represent QA on investigation and NCMR closure
  • Responsible to secure inactive equipment/tools in designated storage area and archiving the corresponding files
  • Any projects or tasks assigned by management

Education and/or Job Experience

  • BS in engineering degree and/or related certifications
  • A minimum of three years of equipment management experience with a working knowledge of equipment qualification, calibration and PM procedures and practices. 
  • Three years of related experience in an FDA regulated industry is preferred
  • Must have knowledge of metrology skills including a sound understanding of dimensional tolerances and usage of precise mechanical measurement instruments
  • Must demonstrate ability to be accurate and identify procedural inaccuracies and make recommendations for ongoing improvements and effectively implement changes
  • Must demonstrate ability to work independently, make effective decisions, and resolve technical issues
  • Must demonstrate effective verbal and written communication and be able to effectively interact with all levels of the organization across all departments and proactively identify issues and recommendations improvements
  • Must demonstrate the ability to work effectively in teams to achieve results
  • Basic proficiency with Microsoft Office Products such as Word and Excel or equivalent software applications is preferred

Skills and Specifications

  • Attention to detail and organizational skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to multi-task and manage a diverse mix of issues, responsibilities and challenges
  • Flexible and adaptable to changing environment and priorities 
Apply
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