Biopharm Manufacturing Associate II-1

The Rockville Biopharm site exists to produce and deliver biopharmaceutical drug substance of the highest quality in a safe, compliant, reliable and cost-effective manner for our patients. Our vision is to be wholly entrusted to make innovative, high quality medicines by leveraging the best talent and technology, on a platform of continuous improvement, to supply every patient, every time.  

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:  

Possesses expertise and functional knowledge of the following areas and ability to perform the activity with minimal guidance and producing quality results:  

• 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.  

Basic understanding and knowledge of the following areas and ability to perform the activity with some supervisory guidance:  

• Knowledge and application of standard ERP processes in M-ERP following global and local procedures.   

• Knowledge and skill required to manage and use automation and emerging digital platforms.   

• Ability to choose a type of communication that is most effective in a given situation.   

• Understanding of the GSK Production System (GPS) continuous improvement system and apply the GPS mindsets and behaviors.  

• The ability to provide teaching and facilitation skills in training delivery.  

General familiarity with the following areas:  

• Build positive relationships with others and conduct negotiation to establish win/win solutions.    

• Ability to articulate production equipment and / or manufacturing process problems to ensure accurate and detailed communication.   

• General knowledge of Microsoft Office Applications (Excel, Word, and Outlook)  

Why you? 

Basic Qualifications: 

We are looking for professionals with these required skills to achieve our goals: 

• High School Diploma or equivalency  

• 1+ 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.<