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Packaging Lead
Posted: 02/23/2026
Industry: Biotech/ Clinical/ R&D/ Science
Job Number: 26-25744
Pay Rate: 40-45 USD/Hour
Job Description
Job Description:
The Production Lead supports clinical trial projects through the packaging of clinical trial supplies;ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The CSS Production Lead is responsible for the overall process for the area, ensuring on-time startup and effective and compliant processing through the shift. The Production Lead ensures that all lines have the proper staff, support, and training to execute the production batch records. This position reports to the Production Manager.
Education and Experience:
Bachelor s degree required or equivalent relevant work experience.
Minimum of 6 years of industry experience, clinical trial packaging, or related packaging/manufacturing/operations experience required.
Minimum of 4 years of leading teams.
Essential Functions:
Accurately review packaging batch records prior to packaging process to ensure processing instructions are followed in accordance with SOPs
Prepare and complete documentation in compliance with SOPs and cGMP
Review packaging batch records for completeness and appropriate documentation and ensure that any corrections to the packaging batch record are completed accurately
Inspect drug product, components, and clinical labels for defects, blemishes or missing text prior to and during production
Proficiently perform Job Safety Analysis (JSA) on new equipment
Ability to analyze processes, recommend changes and drive improvements
Trained in the use of Entropy (safety system) and TrackWise (quality system)
Perform Gemba walks
Use visual management boards and signage
Support supervisor in daily activities
Assist with Safety and Quality investigations, utilizing Root Cause Assessment techniques, and CAPA identification
Must have a Patient First customer focus mindset
Will reinforce and support a respectful and professional workplace among all team members
Must be able to successfully manage competing priorities and personalities
Provide front line leadership support and decision making to staff and act as supervisor for Packaging and Room operations when Supervisor is unavailable or needed
Assist with action item completions (e.G., corrections in TrackWise)
Assist with scheduling planned maintenance activities for equipment and facilities and any corresponding return to service
Attend project kickoff meetings and effectively contribute to the plan
Monitor Ready-to-Execute and coordinate on-time start activities for production
Review equipment and room setups against JSAs, batch records, and SOPs make changes accordingly to drive compliance and productivity
Capture daily information from Short Interval Control boards and populate daily shift notes as well as other required metric sheets
Other duties as assigned
Knowledge/Skills Requirements:
Demonstrated ability to read, write, and communicate effectively
Proven written and verbal communication skills
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to work in a team environment
Strong organizational skills in alignment of Lean Six Sigma 5S standards
Ability to work effectively under pressure to meet competing workplace demands while maintaining the highest level of quality in all work performed
Proficient computer skills including, but not limited to e-mail, Microsoft Word, Microsoft Excel, Internet Explorer, Inventory Systems, Quality Systems, Supply Flex
Strong mathematical skills
Proven leadership and team management skills
Ability to communicate and collaborate with external vendors if necessary
The Production Lead supports clinical trial projects through the packaging of clinical trial supplies;ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The CSS Production Lead is responsible for the overall process for the area, ensuring on-time startup and effective and compliant processing through the shift. The Production Lead ensures that all lines have the proper staff, support, and training to execute the production batch records. This position reports to the Production Manager.
Education and Experience:
Bachelor s degree required or equivalent relevant work experience.
Minimum of 6 years of industry experience, clinical trial packaging, or related packaging/manufacturing/operations experience required.
Minimum of 4 years of leading teams.
Essential Functions:
Accurately review packaging batch records prior to packaging process to ensure processing instructions are followed in accordance with SOPs
Prepare and complete documentation in compliance with SOPs and cGMP
Review packaging batch records for completeness and appropriate documentation and ensure that any corrections to the packaging batch record are completed accurately
Inspect drug product, components, and clinical labels for defects, blemishes or missing text prior to and during production
Proficiently perform Job Safety Analysis (JSA) on new equipment
Ability to analyze processes, recommend changes and drive improvements
Trained in the use of Entropy (safety system) and TrackWise (quality system)
Perform Gemba walks
Use visual management boards and signage
Support supervisor in daily activities
Assist with Safety and Quality investigations, utilizing Root Cause Assessment techniques, and CAPA identification
Must have a Patient First customer focus mindset
Will reinforce and support a respectful and professional workplace among all team members
Must be able to successfully manage competing priorities and personalities
Provide front line leadership support and decision making to staff and act as supervisor for Packaging and Room operations when Supervisor is unavailable or needed
Assist with action item completions (e.G., corrections in TrackWise)
Assist with scheduling planned maintenance activities for equipment and facilities and any corresponding return to service
Attend project kickoff meetings and effectively contribute to the plan
Monitor Ready-to-Execute and coordinate on-time start activities for production
Review equipment and room setups against JSAs, batch records, and SOPs make changes accordingly to drive compliance and productivity
Capture daily information from Short Interval Control boards and populate daily shift notes as well as other required metric sheets
Other duties as assigned
Knowledge/Skills Requirements:
Demonstrated ability to read, write, and communicate effectively
Proven written and verbal communication skills
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to work in a team environment
Strong organizational skills in alignment of Lean Six Sigma 5S standards
Ability to work effectively under pressure to meet competing workplace demands while maintaining the highest level of quality in all work performed
Proficient computer skills including, but not limited to e-mail, Microsoft Word, Microsoft Excel, Internet Explorer, Inventory Systems, Quality Systems, Supply Flex
Strong mathematical skills
Proven leadership and team management skills
Ability to communicate and collaborate with external vendors if necessary
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