Packaging Team Lead, 2nd shift
About The Position
INCOG BioPharma Services is seeking a Packaging Team Lead with expertise in packaging sterile pharmaceutical drug products. The role monitors packaging processes, reviews executed batch records and forms, and guides daily team activities to ensure production standards, product quality, and compliance with quality systems, procedures, and current good manufacturing practices (cGMP). The lead helps minimize equipment downtime and collaborates with internal partners, clients, and vendors. The position supports packaging teams of 6 to 10 associates handling syringes, vials, and device assemblies. It includes performing and reviewing packaging activities and production documentation, identifying defects and equipment issues, training employees, and assisting other manufacturing functions as needed. The role is based at INCOG BioPharma’s Fishers, Indiana offices unless otherwise specified. The campus is smoke-free.
Requirements
- High school diploma.
- At least 1 year of GMP pharmaceutical experience in drug product inspection and/or packaging.
- Awareness of regulatory requirements and industry guidance applicable to cGMPs for combination products, including 21 CFR Part 4, FDA Guidance for Industry: Current Good Manufacturing Practice Requirements for Combination Products (2015), and ISO 13485:2016 Medical devices — Quality management systems.
- Authorization to work in the United States on a full-time basis; INCOG will not sponsor work authorization or visas for this role.
Nice To Haves
- Previous manufacturing leadership experience.
- Good math and documentation skills.
- Ability to perform repetitive tasks.
- Ability to learn and adapt to innovative ideas.
- Good observation skills.
- Initiative-taking and collaborative approach.
- Effective organization skills and diligence.
- Ability to work with minimal supervision.
Responsibilities
- Assist Packaging Supervision in supporting a team of 6 to 10 associates packaging syringes, vials, and device assemblies.
- Follow production and manufacturing procedures.
- Perform in-process checks to identify packaging defects and machinery issues.
- Escalate packaging issues to Supervision as required.
- Reconcile finished packaged product and defects.
- Provide input for process and document improvements.
- Operate equipment in compliance with SOPs.
- Assure compliance with cGMP requirements.
- Perform labeling and packaging activities for finished product.
- Complete and review associated production records, logbooks, and forms.
- Assist other manufacturing functions as required.
- Train new employees to perform packaging activities.
- Collaborate and communicate with cross-functional teams.
- Work flexible hours to ensure production facility coverage.
- Monitor packaging processes and perform daily in-process reviews of executed batch records and form entries.
- Drive team activities for packaging sterile drug products while meeting production standards, maintaining product quality, and minimizing or preventing equipment downtime.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
