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 without 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. 
• Set-up of fixed and mobile process equipment and parts with CIP skids to carry out validated cleaning and sterilization processes.
• Develop and follow appropriate standard operating procedures (SOPs), protocols and batch records to safely perform process operations and document compliantly with good documentation and data integrity practices.
• Review all appropriate production documentation and insure GMP compliance and metric attainment.
• Knowledge and skill required to manage and use automation and emerging digital platforms.
• Knowledge and experience with process operations, equipment and instrument monitoring and trending to enable proactive identification of issues to escalate and correct with applicable departments.
• Knowledge and application of standard ERP processes in M-ERP following global and local procedures.
• Adherance to regulatory guidelines and global corporate and local procedures.
• Ability to choose a type of communication that is most effective in a given situation. Such competency empowers individuals to achieve the goals of any communication in a manner that is best suited for all parties involved.
• Ability to articulate production equipment and / or manufacturing process problems to ensure accurate and detailed communication.
• Transfers information to audiences of varying levels of technical knowledge, so that each member of the audience clearly understands the message.
• 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:

• An appreciation of cultural differences and diversity in the workplace.
• Build positive relationships with others and conduct negotiation to establish win/win solutions.  
• Developing team capability to learn with knowledge of coaching styles, listening and questioning techniques, feedback models and emotional intelligence.
• Recruit, hire and maintain appropriate staff levels to meet operational and strategic goals
• Ability to explain and utilize techniques to improve and sustain physical energy levels through the day to support resilience on teams.

Why you?

Basic Qualifications:

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

• 5+ years of directly related experience 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 up to 50 lbs

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Understanding the of the basic Federal Drug Administration (FDA) and current Good Manufacturing Practices (cGMP) regulations
• Strong verbal and written skills
• Must be able to follow detailed processing instructions as well as accurately documenting any necessary information
• Demonstrated ability to work effectively in a team
• Bachelor of Science / Bachelor of Art in biological sciences, chemical sciences, engineering or equivalent technical discipline. 

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together.