Biopharmaceutical Associate 1

GSK

1d • $26 - $43

About The Position

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: 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. Ability to choose a type of communication that is most effective in each situation. Knowledge and application of standard ERP processes in M-ERP following global and local procedures. Understanding of the GSK Production System (GPS) continuous improvement system and apply the GPS mindsets and behaviors. Knowledge and skill required to manage and use automation and emerging digital platforms. General knowledge of Microsoft Office Applications (Excel, Word, and Outlook). Additional Responsibilities for Higher Grades (BMA II, Sr. BMA and Lead BMA): Expertise and functional knowledge of the above areas with minimal guidance and producing quality results. Ability to articulate production equipment and/or manufacturing process problems to ensure accurate and detailed communication. Lead in the application of the GSK Production System (GPS) continuous improvement system and apply the GPS mindsets and behaviors in problem-solving. Assist resolution of technical and process problems; Identify, develop, and implement process improvements. Transfers information to audiences of varying levels of technical knowledge, so that each member of the audience clearly understands the message. 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. An appreciation of cultural differences and diversity in the workplace.

Requirements

• High School Diploma or GED
• Ability to work shifts that cover a 24/7 production operation.
• Ability to lift and carry materials up to 50 lbs.
• Ability to work in a clean environment adhering to all cleanliness standards established at site
• The selected candidate will be considered at the appropriate level based on experience
• 1+ years of directly related manufacturing experience in the pharmaceutical or biotechnology industry (BMA II)
• 3+ years of directly related manufacturing experience in the pharmaceutical or biotechnology industry (Sr. BMA)
• 5+ years of directly related manufacturing experience in the pharmaceutical or biotechnology industry (Lead BMA)

Nice To Haves

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

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.
• Ability to choose a type of communication that is most effective in each situation.
• Knowledge and application of standard ERP processes in M-ERP following global and local procedures.
• Understanding of the GSK Production System (GPS) continuous improvement system and apply the GPS mindsets and behaviors.
• Knowledge and skill required to manage and use automation and emerging digital platforms.
• General knowledge of Microsoft Office Applications (Excel, Word, and Outlook).
• Expertise and functional knowledge of the above areas with minimal guidance and producing quality results.
• Ability to articulate production equipment and/or manufacturing process problems to ensure accurate and detailed communication.
• Lead in the application of the GSK Production System (GPS) continuous improvement system and apply the GPS mindsets and behaviors in problem-solving.
• Assist resolution of technical and process problems; Identify, develop, and implement process improvements.
• Transfers information to audiences of varying levels of technical knowledge, so that each member of the audience clearly understands the message.
• 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.
• An appreciation of cultural differences and diversity in the workplace.

Benefits

• Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
• In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED