Biopharmaceutical Operations Specialist

4 weeks ago


Rockville, Maryland, United States GlaxoSmithKline Full time
Job Summary

We are seeking a highly skilled Biopharmaceutical Operations Specialist to join our team at GlaxoSmithKline. As a key member of our production operations team, you will be responsible for leading key activities to progress your career and contribute to the success of our biopharmaceutical operations.

Key Responsibilities
  • Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations.
  • Perform the set-up, operation, cleaning and break-down of process equipment.
  • Perform sampling procedures on various analytical instruments to analyze cell culture, solution and/or product concentration characteristics.
  • Perform process operations, equipment and instrument monitoring and trending to enable proactive identification of issues to escalate and correct with applicable departments.
  • Set-up of fixed and mobile process equipment and parts with CIP skids to carry out validated cleaning and sterilization processes.
  • Follow appropriate standard operating procedures (SOPs), protocols and batch records/logbooks to safely perform process operations and document compliantly with good documentation and data integrity practices.
  • Follow all related safety policies and procedures and put safety first by playing an active role in identifying and correcting unsafe behaviors and conditions.
Requirements
  • High School Diploma or equivalency.
  • 3+ years of directly related manufacturing experience in the pharmaceutical or biotechnology industry.
  • Ability to work shifts that cover a 24/7 production operation.
  • Ability to lift and carry materials weighing as much as 50lbs.
Preferred Qualifications
  • Understanding of the basic Federal Drug Administration (FDA) and current Good Manufacturing Practices (cGMP) regulations.
  • Demonstrated ability to work effectively in a team.
  • Must be able to follow detailed processing instructions as well as accurately documenting any necessary information.
  • Strong verbal and written skills.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.



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