Biopharmaceutical Operations Specialist

7 days ago


Rockville, Maryland, United States GSK Full time
Job Summary

We are seeking a highly skilled Biopharmaceutical Associate I to join our team at GSK. 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 production of high-quality biopharmaceutical drug substance.

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. Operate Filter integrity devices to confirm the integrity of filters pre and post use.
  • 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
  • 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.
Why GSK?

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.



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