The Biomanufacturing Associate I will play an integral role within CRL’s gene therapy manufacturing function by understanding and applying biological, bioprocess, manufacturing, and mechanical principles, processes, procedures, inputs, and outputs, for designated production processes and handovers, within a cGMP and GLP environment. This will ensure the timely production and release of quality products, based on client specifications.
This role will perform a range of routine and semi-routine tasks, some of which are moderately difficult, requiring judgment in resolving issues or making recommendations, with guidance as needed, in order to proficiently execute manufacturing protocols in a regulated environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Under guidance, apply and adhere to SOPs, cGMP, GLP, Quality, and basic Safety standards and requirements when completing tasks.
• Perform a range of routine and semi-routine tasks, in accordance with SOPs, under guidance, in one of the following areas:
o Basic Upstream Activities (e.g., assist with solutions, media aliquot, and buffer preparation and autoclave materials for cell culture, staging of raw materials, seed train, bioreactor set up, fermentation monitoring and/or harvest).
• Follow verbal and written instructions (e.g., SOPs), when performing planned manufacturing activities, in alignment with the batch record, and under guidance.
o Performing routine sampling (e.g., collecting and preparing) and inspections.
o Assisting in material transfer processes.
• With guidance, use basic quality documents and apply Good Documentation Practices.
• Ensure data integrity by accurately documenting, reviewing, and correcting work prior to submission.
• Identify, record, and report observed process variances and deviations in real time.
• Apply and adhere to SOPs, safety guidelines, and manufacturing instructions when completing process tasks and when operating equipment. Prepare, clean, maintain, and operate equipment and tools.
• Recognize common safety issues and report all injuries and safety incidents immediately.
• Adhere to safe working practices and comply with site-based guidelines to avoid the consequences of error by applying:
o Cleanroom and aseptic behaviors and procedures.
o Proper Personal Protective Equipment (PPE) and gowning requirements.
o Proper preparation, disinfection, sterilization, and sanitation methods and processes for equipment, etc.
o The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials.
o Universal precautions with respect to OSHA guidelines.
o Appropriate organization, sanitizing, and stocking of work area to avoid unsafe situations.
• Seek input from others, positively respond to feedback, make appropriate course corrections to learn from and avoid repeating the same mistakes.
• Attend and complete relevant training, apply to work tasks, and maintain training documentation.
• Responsible to ensure 100% on-time completion of new hire training plan.
• Is punctual and flexible with work schedule, tasks, etc. to meet customer and other critical demands.
• Perform other responsibilities as required.