2nd Shift Production Lead

The Production Room Leader, acting under direct supervision, executes and oversees all phases of clinical
packaging, labeling, manufacturing, and assembly of investigational drug product that includes but is not
limited to blistering, bottling, carding, encapsulation, manufacturing, labeling, and assembly. He/She
prepares and completes packaging supplies and required documentation in accordance with approved
manufacturing instructions (MIs), company SOPs and cGMP Regulations.

Execute packaging of clinical supplies as determined by the approved manufacturing instructions
(MIs) in accordance with company SOPs and cGMP Regulations.
Complete support documentation associated with the execution of the packaging operation(s) being
performed.
Ensure that packaging areas are maintained in accordance with company SOPs and cGMP
Regulations before, during, and after any packaging operation.
Able to operate packaging equipment.
Train Packaging Technicians on job specific duties.
Monitor Packaging Technicians in assigned packaging area to ensure compliance with company
SOPs, manufacturing instructions (MIs), and cGMP Regulations.
Adhere to set safety standards.
Achieve expected performance measures.

Qualifications
High School diploma or general education degree (GED) equivalent
1 years of previous packaging of clinical supplies or cGMP experience required.
Excellent oral and written communication skills to communicate with the team, peers,
management, and external contacts.
Demonstrated ability to monitor and supervise packaging operations.
Demonstrate the ability to lead as a change agent, handle multiple tasks simultaneously, and
negotiate and meet critical timelines.
Responsible for cleaning of cGMP packaging areas, equipment and utensils on an as needed basis