R&D Laboratory Coordinator

The R&D Laboratory Coordinator position reports directly to the Sr Director of Technical Operations. This position is instrumental in coordinating activities directly involving R&D Manufacturing, R&D sample management, client R&D material management, R&D laboratory upkeep and support for scheduled R&D studies. They are responsible for receiving, distributing, managing and maintaining samples for internal and external testing as they are generated from planned product development studies. In addition, this position is responsible for ensuring that all R&D laboratory consumables and reagents are maintained and ordered per Technical Operations team requests.

• Responsible for ensuring the R&D Laboratory is in a state of readiness to support planned product development activities.
• Coordinates and schedules the receipt, sampling and testing of samples for internal and outsourced testing.
• Maintains associated Sample Submission Forms from each department requiring Quality Control testing.
• Oversees the sample flow from clients and production, maintaining an organized log of samples submitted to the laboratories.
• Ensures client R&D materials, laboratory consumables and reagents are inventoried, properly stored and well-maintained.
• Coordinates external calibration and preventative maintenance activities for laboratory instruments.
• Supports R&D study execution as directed by R&D Scientists and Technical Services team members.
• Leads 5S program implementation, continued maintenance and glassware cleanliness to ensure the lab stays “inspection ready”.
• Creates purchase orders for laboratory needs through Aestiva.
• Track all deliverables associated with stability and outsource testing.
• Manage all shipping and supply chain requests from the Quality Control Laboratory.
• Monthly laboratory checklist and logbook reviews.

• Bachelor’s degree in chemistry, biology, or related science and 2+ years of related experience in the pharmaceutical industry in a laboratory, stability, or quality assurance role
• Proficiency with technical writing in cGMP or FDA regulated manufacturing environment
• Ability to work in a fast-paced environment and manage multiple projects and objectives for on-time event closure

• Able to be proactive, action-oriented, and adapt to change
• Strong written and verbal communication skills

• Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems
• Ability to understand and apply GMP regulations as they relate to pharmaceutical manufacturing

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.