Production Supervisor - Caligor Coghlan : Job Details

WHO WE ARE

Caligor Coghlan ( CalCog ) is dedicated to optimizing the clinical supply chain, helping to speed the delivery of life-changing therapeutic innovations to patients worldwide.

We feel good about the work that we do – for more than 29 years, CalCog has been dedicated to supporting the R&D supply chain. With the infrastructure, expertise, and quality management systems of a large company and the speed and responsiveness of a small company, CalCog is a valuable clinical supply resource for small and medium-sized pharmaceutical and biotech organizations.

As a global company, our services include clinical packaging design, clinical packaging and labelling, global storage and distribution, commercial and ancillary product procurement, and medical product supply management to support post-trial and early access programs. We pride ourselves in making it our business to find a better way to deliver for our clients and the patients they serve. Our dedicated people care - about their work, their team, and the results we strive to deliver every day.

If you are looking for a role that supports the types of endeavors listed above in the world of drug supply services, where what you do and how you do it will make a difference, then this position is for you.

POSITION SUMMARY

The Production Supervisor – Secondary Packaging is responsible for overseeing clinical trial secondary packaging operations, ensuring compliance with cGMP, study-specific requirements, and global regulatory standards. This includes coordination and oversight of packaging activities, label control, and ensuring timely availability of clinical supplies.

ORGANIZATIONAL POSITION

This post holder reports directly to the Operations Manager, or designee. The role involves leading the Production team at CalCog's Bastrop facility, optimizing processes, managing resources, and supporting continuous improvement initiatives.

RESPONSIBILITIES

• Supervise and execute secondary packaging operations (i.e. labeling, kitting, walleting, heat sealing, etc.) for clinical trial materials.
• Ensure packaging activities are conducted according to master production records, study protocols, and SOPs.
• Collaborate with Quality Assurance to ensure compliance and readiness for inspection.
• Review and approve batch records, packaging instructions, and label proofs.
• Maintain inventory control of packaging components, printed labels, and supplies.
• Troubleshoot issues related to packaging, label reconciliation, and component compatibility.
• Train and oversee packaging technicians during packaging campaigns.
• Ensure accurate documentation and reconciliation of all packaging and labeling activities.
• Assist in continuous improvement projects and validation efforts related to packaging equipment and processes.
• Participate in audits, training programs, and continuous improvement initiatives.
• Meet established timelines and SLAs for completion of all activities.
• In accordance with policy and confidentiality disclosure safeguards, protect the safety and integrity of company and client information.
• Perform other duties as assigned, according to the changing needs of the business.

QUALIFICATIONS, EXPERIENCE AND SKILLS

• Bachelor's degree in life sciences, pharmacy, engineering, or related field (preferred); equivalent experience considered.
• 3+ years of experience in clinical supply, pharmaceutical packaging, or GMP manufacturing.
• Strong understanding of cGMP, GDP, ICH, and applicable regulatory requirements.
• Experience with label control, comparator packaging, randomization, and blinding techniques is a plus.
• Excellent attention to detail, organizational skills, and communication ability.
• Experience in a controlled environment and handling temperature-sensitive materials is preferred.
• Ability to work in a fast-paced, highly regulated environment while managing multiple priorities.