Scientist I

Position Summary

We have an opportunity for a Scientist I to join our team and contribute to the Biologics Department. The role involves providing and reporting data required by project contracts, supporting regulatory submissions, release and stability testing, and development projects. This position offers the chance to work on large molecule therapeutics and contribute to meaningful scientific outcomes.

The Role

• Develop and execute laboratory work for large molecule therapeutics using customer milestones and site performance standards.
• Work with sample types including in-process, release, or stability for Chemistry, Manufacturing, and Controls (CMC) support.
• Apply techniques such as mammalian cell culture, sterile technique, in vitro cell-based assays, ELISA assays, molecular biology (qPCR, PCR), kinetic binding assessment (BLI or SPR), and flow cytometry.
• Perform method validation, transfer, and development activities as needed.
• Conduct testing under current Good Manufacturing Practice (cGMP) standards.
• Author and review technical documents including protocols, test methods, reports, and certificates of analysis.
• Train, coach, or mentor others on technical and professional topics.
• Supervise technical staff and manage work assignments and performance.
• Serve as Project Technical Lead responsible for project outcomes and customer interaction.
• Execute efficiency improvement projects with guidance and identify business opportunities on a project basis.
• Perform other duties as assigned.

The Candidate

• Bachelor's Degree: 7+ years of relevant experience preferred or based on performance at Catalent.
• Master's Degree: 2+ years of relevant experience preferred or based on performance at Catalent.
• Doctorate Degree: 0+ years of relevant experience preferred or based on performance at Catalent.
• Knowledgeable in relevant techniques such as mammalian cell culture, sterile technique, in vitro cell-based assays, ELISA assays, molecular biology (qPCR, PCR), kinetic binding assessment (BLI or SPR), and flow cytometry.
• Familiarity with drug development milestones and their context.
• Excellent written and verbal communication skills with internal and external customers.
• Supervisory skills expected for Scientists with direct reports.
• Ability to organize and manage teams addressing lab issues or special projects.
• Recognize unmet customer needs and propose solutions.
• Effectively back up supervisor to address technical or business issues.
• Focus on personal and team time management and efficiency.
• Well organized with the ability to multitask and meet deadlines under pressure.
• May publish or present externally.

Preferred Skills & Background

GMP experience