Staff Scientist

11200 Hudson Rd, Woodbury, MN 55129, USA Req #1305
Tuesday, June 4, 2024

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

 

Ready to work with purpose? Look no further, we are hiring for a talented Staff Scientist to join our Woodbury Team.

 

Summary of Position
The person hired for the position of Container Closure Integrity Testing (CCIT) Validation Specialist will play a key role in the development and validation of CCIT methodology including use of High Voltage Leak Detection, Vacuum Decay, Helium Leak Detection, Laser Headspace Analysis and Residual Seal Force. The CCIT Validation Specialist will also train analysts to support CCI method development and testing activities. The CCIT Validation Specialist will be responsible for the procurement and maintenance of CCIT equipment and act as a technical expert both internally and with external clients.

 


Job Responsibilities

  • Ensure world-class safety within the laboratory and Kindeva Woodbury Facility.
  • Train and mentor a small group of analysts to support CCI method development and testing.
  • Conduct method development and analyses in adherence to GMP and SOPs.
  • Maintain and provide knowledge and expertise on the Regulatory requirements for CCI testing.
  • Act as CCI testing expert for both internal and external clients and partners.
  • Use LIMS system to document and archive testing results.
  • Use electronic laboratory notebook to document work in compliance with GMP.
  • Be able to multitask and remain flexible to changing project priorities.
  • Possess the ability to write test method documents, protocols, and reports with minimal guidance.
  • Review and update lab documentation such as SOPs and methods to reflect current processes.
  • Work well both as an individual and in a team environment.
  • Other duties as assigned.

 

Minimum Requirements

  • Bachelor’s degree or higher in a science discipline from an accredited university.
  • Minimum 2 years CCI testing and method development experience in a GMP laboratory.

 

Preferred Qualifications

  • Minimum 5 years CCI testing and method development experience in a GMP laboratory.
  • Knowledge and demonstrated experience with USP <1207> requirements.
  • Demonstrated experience with packaging and CCI testing requirements for sterile products.
  • Demonstrated strong oral and written communication skills.
  • Demonstrated technical writing and data analysis skills.
  • Experience with Light house, Ethos and Minitab software.

#LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying. 
 

Covid-19: 
 

Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
 

Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures. 
 

Equal Opportunity Employer:
 
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Other details

  • Job Family Technical Professional IV
  • Job Function Technical Professional
  • Pay Type Salary
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Location on Google Maps
  • 11200 Hudson Rd, Woodbury, MN 55129, USA