
Description
Our client, a global biopharmaceutical company that delivers treatments for patients with a significant unmet need, has an immediate opening for a Manufacturing Associate.
This individual will periodically support other line functions including shipping, receiving, and purchasing. It is preferred, but not required, that the candidate have experience with disposable technologies and solution preparation. The candidate must be highly motivated, eager to learn, science driven, and results-oriented in a team environment.
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 company policies
- Assist with raw material inventory, shipping/receiving, glass wash, and autoclave
- Assist with scheduling, forecasting, material demands, and sample submission
Requirements:
- BS degree, 0-2 years’ 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 but not required
- Flexibility and team-work 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
- Flexibility to support weekend operations as needed