Finding 11 experts in 6 weeks for a high-impact source qualification project.

high-impact source qualification project

The challenge

A project to manage packaging and sterility issues. 

The client, one of the largest U.S. generic drug manufacturing companies for over the counter (OTC) self-care products, was facing packaging and sterility issues. The company wanted to improve sourcing diversification, a pillar in its supply chain reinvention program. They planned to mitigate risk and gain margin benefit by establishing dual or alternate source qualification of certain key materials. The project was planned to last 2+ years, demanding a group of dedicated, specialized experts. But the client’s internal team didn't have the time to take on the extra work. 

The solution

A resource delivery model across functional teams.

Kelly Science & Clinical implemented a team that spanned client functions for Analytical R&D, Quality Control, Supplier Quality, Project Management, and Validation. The project required 5 AR&D Scientists and 3 QC Analytical Scientists, plus a Supplier Quality Associate, Tech Ops PM, and Validation Engineer. In order to attract and retain such a high level of embedded talent reporting to cross-functional teams, Kelly deployed an SOW-based resource delivery solution. This model offered additional benefits to talent—including 200 hours of PTO, enhanced Medical, Dental, Vision, and 401K+ plans—which allowed functional leaders to attract top experts from full-time roles to commit to the high-impact project. 

The value

A team of 11 specialty resources in under 42 days.

The team of high-level experts was built in less than 6 weeks, and all retained to successfully hit project milestones, on schedule. They followed the client’s Material Review Board (MRB) process to qualify new sources of raw materials for use in their existing formulations, and to add them as approved materials where needed in their Abbreviated New Drug Applications on file with the FDA. Meanwhile, the client kept the flexibility to convert those people to become full-time hires during or after the project. Ultimately, Kelly helped solve a critical challenge when the client simply didn’t have the resources. 

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