Our client, a global biopharmaceutical company, has an immediate opening for a Manufacturing Associate. This role will provide execution of upstream manufacturing batch records, assist in maintaining the suite, and provide documentation of all activities to meet cGMP requirements.

Responsibilities:

• Small and large scale (1-200L) buffer and media production
• Support upstream and downstream operations for new product development material supply needs and demonstration runs for multiple programs (sampling, aliquoting, and execution)
• Execution of upstream manufacturing batch records for cell culture operations including cell expansion, production, and harvest
• Follow work instructions and/or SOPs, with focus on ‘right the first time’ executions
• Assist in maintaining suite, supplies, equipment, logbooks, and data in accordance with site SOPs and policies
• Maintain proper documentation, training, and procedures to support cGMP activities per policies
• Assist with raw material inventory, shipping/receiving, glass wash, and autoclave
• Assist with scheduling, forecasting, material demands, and sample submission
• Daily standardization of small equipment and systems

Requirements:

• BS degree, 0-2 years of experience in the biotech industry
• Experience in mammalian cell culture operations including standard analytical methods, sterile techniques, and cell expansion
• Knowledge of a GMP regulated environment and an understanding of regulatory/quality requirements for clinical stage manufacturing preferred
• Flexibility and teamwork focus to organize, communicate, and influence, with an unquestionable level of integrity
• Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement
• Ability to multi-task and deliver objectives on time in pressurized, fast-paced environment
• MS Office experience and strong mathematical skills
• Flexibility to support weekend operations as needed