Process Transfer and Validation Coordinator in Andover, MA at Apex Life Sciences

Date Posted: 4/24/2018

Job Snapshot

Job Description


JOB SUMMARY

The Process Transfer and Validation Coordinator is responsible for coordinating and supporting activities related to the transfer and validation of biologics drug substance manufacturing process to the Andover manufacturing facilities.

RESPONSIBILITIES

  • Coordinating and scheduling technology transfer, validation, and production related activities
  • Management of the identification, collection, distribution, analysis, and result compilation of process samples associated with validation and production activities
  • Authoring of technical protocols, reports, and regulatory submissions
  • Compilation and verification of process data used in technical reports and regulatory submissions
  • Maintenance of collaboration and productivity software tools used to facilitate technology transfer, validation, and production planning
  • Providing administrative support for activities associated with technology transfer, validation, and production planning

REQUIREMENTS

  • Bachelor degree in science or engineering disciplines
  • 2 years of experience in biopharmaceutical production, testing, or process development
  • 1 year of experience in document management system
  • 1 year of experience in laboratory information management system (LIMS) or equivalent desired
  • Experience with MS Office required, MS Project preferred
  • Experience Project Scheduling or Technical Writing 

***For immediate consideration, please email an updated resume to ljohnson@apexlifesciences.com with 'Validation Coordinator - Andover' in the subject line***

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.