The Clinical Supplies 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 (MI’s), company SOP’s and cGMP Regulations. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Execute packaging of clinical supplies as determined by the approved manufacturing instructions (MI’s) in accordance with company SOP’s 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 SOP’s and cGMP Regulations before, during, and after any packaging operation.

• Able to operate packaging equipment.

• Train Clinical Supplies Packaging Technicians on job specific duties.

• Monitor Clinical Supplies Packaging Technicians in assigned packaging area to ensure compliance with company SOP’s, manufacturing instructions (MI’s), and cGMP Regulations.

• Adhere to set safety standards.

• Participate actively in regular meetings.

• Achieve expected performance measures.

• Other duties as assigned.

  QUALIFICATIONS

  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• High School diploma or general education degree (GED) equivalent

• 1+ years of previous clinical supplies packaging 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.