Biopharmaceutical Associate I

Role Summary

Biopharmaceutical Associate I, Rockville, MD. Responsible for performing media preparation, cell culture and purification operations, and operating and maintaining process equipment in a GMP manufacturing environment. Performs sampling, monitoring, documentation, and routine maintenance to support safe, compliant production of biopharmaceutical drug substances.

Responsibilities

• Preparation, cleaning, sterilization, batching, pasteurization or filtration, and delivery of media and solutions for cell culture and purification operations.
• Set up, operate, clean, and break down process equipment.
• Perform sampling on analytical instruments to analyze cell culture, solution, and 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 fixed and mobile process equipment and CIP skids to carry out validated cleaning and sterilization processes.
• Follow 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).

Qualifications

• Required: High School Diploma or GED
• Required: Ability to work shifts that cover a 24/7 production operation
• Required: Ability to lift and carry materials up to 50 lbs
• Required: Ability to work in a clean environment adhering to site cleanliness standards
• Required: The selected candidate will be considered at the appropriate level based on experience
• Required: 1+ years of directly related manufacturing experience in the pharmaceutical or biotechnology industry (BMA II)
• Required: 3+ years of directly related manufacturing experience in the pharmaceutical or biotechnology industry (Sr. BMA)
• Required: 5+ years of directly related manufacturing experience in the pharmaceutical or biotechnology industry (Lead BMA)
• Preferred: Must be able to follow detailed processing instructions as well as accurately documenting any necessary information
• Preferred: Demonstrated ability to work effectively in a team
• Preferred: Ability to speak, read, write, and understand English
• Preferred: Strong verbal and written skills
• Preferred: Understanding of the basic FDA and current Good Manufacturing Practices (cGMP) regulations

Education

• Bachelor of Science, Bachelor of Arts, or Associate’s degree in biological sciences, chemical sciences, engineering, or equivalent technical discipline

Skills

• Effective communication and ability to adapt communication style to different audiences
• Knowledge of ERP/M-ERP systems and GPS continuous improvement mindset
• Experience with automation and emerging digital platforms
• Proficiency with Microsoft Office Applications (Excel, Word, Outlook)